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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02880956
Registration number
NCT02880956
Ethics application status
Date submitted
24/08/2016
Date registered
26/08/2016
Date last updated
26/08/2022
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease
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Scientific title
A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease
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Secondary ID [1]
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2016-001634-10
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Secondary ID [2]
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M15-566
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-8E12
Treatment: Drugs - placebo for ABBV-8E12
Placebo Comparator: Placebo - Placebo for ABBV-8E12 every 4 weeks for 96 weeks
Experimental: ABBV-8E12 300 mg - ABBV-8E12 300 mg every 4 weeks for 96 weeks
Experimental: ABBV-8E12 1000 mg - ABBV-8E12 1000 mg every 4 weeks for 96 weeks
Experimental: ABBV-8E12 2000 mg - ABBV-8E12 2000 mg every 4 weeks for 96 weeks
Treatment: Drugs: ABBV-8E12
ABBV-8E12 solution for IV infusion
Treatment: Drugs: placebo for ABBV-8E12
placebo solution for intravenous (IV) infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline Over Time in CDR-SB Score
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Assessment method [1]
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The CDR-SB is a numeric scale used to quantify the severity of symptoms of dementia. A qualified health professional assesses a participant's cognitive and functional performance in 6 areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The CDR scale gives a score from 0 to 3 for each of the 6 areas, with a lower value being desirable. The sum of these 6 areas, the CDR-SB score, can range from 0 to 18, with a lower value being desirable.
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Timepoint [1]
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Baseline, Week 24, Week 48, Week 72, Week 96
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Primary outcome [2]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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Assessment method [2]
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A TEAE was defined as an adverse event (AE) that began on or after the first study drug dose date and no more than 20 weeks after the last dose of study drug. An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. Serious AEs (SAEs) were defined as an event that results in death, is life-threatening, results in hospitalization or prolongs hospitalization, is a congenital abnormality, results in persistent or significant disability/incapacity, or is an important medical event. Events were rated in severity as mild, moderate, or severe, and were categorized as having a reasonable possibility or no reasonable possibility of relationship to study drug.
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Timepoint [2]
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From first dose of study drug up to last dose of study drug plus 20 weeks (up to Week 112)
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Secondary outcome [1]
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Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
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Assessment method [1]
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Timepoint [1]
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Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
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Secondary outcome [2]
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Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
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Assessment method [2]
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Timepoint [2]
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Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
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Secondary outcome [3]
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Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
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Assessment method [3]
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Timepoint [3]
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Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
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Secondary outcome [4]
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Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
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Assessment method [4]
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Harmonic mean is presented in the data table.
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Timepoint [4]
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Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
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Secondary outcome [5]
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Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
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Assessment method [5]
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The AUC0-28 for Dose 1 included the following timepoints: pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 5, Day 15 and Day 29 (trough level before Dose 2).
The AUC0-28 for Dose 4 included the following timepoints: Day 85 pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 89, Day 99 and Day 113 (trough level before Dose 5).
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Timepoint [5]
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Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details.
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Secondary outcome [6]
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Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
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Assessment method [6]
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Timepoint [6]
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Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
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Secondary outcome [7]
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AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses
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Assessment method [7]
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The AUC0-28/dose for Dose 1 included the following timepoints: pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 5, Day 15 and Day 29 (trough level before Dose 2).
The AUC0-28/dose for Dose 4 included the following timepoints: Day 85 pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 89, Day 99 and Day 113 (trough level before Dose 5).
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Timepoint [7]
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Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details.
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Secondary outcome [8]
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Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total Score
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Assessment method [8]
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The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in mild cognitive impairment (MCI) patients. The Total Score of the ADAS-Cog-14 ranges from 0 to 90, with a higher score representing greater impairment.
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Timepoint [8]
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Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [9]
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Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score
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Assessment method [9]
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The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Comprehension of Spoken Language score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
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Timepoint [9]
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Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [10]
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Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score
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Assessment method [10]
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The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Constructional Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
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Timepoint [10]
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Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [11]
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Change From Baseline Over Time in ADAS-Cog-14 Commands Score
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Assessment method [11]
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0
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Commands Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
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Timepoint [11]
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Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [12]
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Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score
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Assessment method [12]
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0
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Delayed Word Recall Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment.
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Timepoint [12]
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Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [13]
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Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score
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Assessment method [13]
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0
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Ideational Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
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Timepoint [13]
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Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [14]
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Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score
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Assessment method [14]
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0
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Maze Task Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
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Timepoint [14]
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Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [15]
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Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score
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Assessment method [15]
0
0
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Number Cancellation Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
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Timepoint [15]
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Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [16]
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Change From Baseline Over Time in ADAS-Cog-14 Naming Score
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Assessment method [16]
0
0
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Naming Score of the ADAS-Cog-14 ranges from 0 to 5 with a higher score representing greater impairment.
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Timepoint [16]
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Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [17]
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Change From Baseline Over Time in ADAS-Cog-14 Orientation Score
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Assessment method [17]
0
0
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Orientation Score of the ADAS-Cog-14 ranges from 0 to 8, with a higher score representing greater impairment.
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Timepoint [17]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [18]
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Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score
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Assessment method [18]
0
0
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Recall - Number of Words Not Recalled Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment.
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Timepoint [18]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [19]
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Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score
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Assessment method [19]
0
0
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Remember Word Recognition Instructions Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
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Timepoint [19]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [20]
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Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score
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Assessment method [20]
0
0
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Spoken Language Ability Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
Query!
Timepoint [20]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [21]
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Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score
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Assessment method [21]
0
0
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Find Difficulty Spontaneous Speech Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.
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Timepoint [21]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [22]
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0
Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score
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Assessment method [22]
0
0
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Recognition Score of the ADAS-Cog-14 ranges from 0 to 12, with a higher score representing greater impairment.
Query!
Timepoint [22]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [23]
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0
Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score
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Assessment method [23]
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0
The FAQ measures level of assistance (functional disability) needed for carrying out instrumental activities in daily living (iADLs). The FAQ score ranges from 0 - 30 and consists of 10 items (each scored from 0 - 3), which measure a specific iADL in the past 4-weeks: [1) writing checks, paying bills, keeping financial records; 2) assembling tax or business records; 3) shopping alone; 4) playing a game of skill; 5) making coffee or tea; 6) preparing a balanced meal; 7) keeping track of current events; 8) attending to and understanding a television program, book, or magazine; 9) remembering appointments, family occasions, medications; and 10) traveling out of the neighborhood]. Performance in each category is rated from 0 - 3 as follows: 0 - normal; 1 - has difficulty, but does by self; 2 - requires assistance; or 3 - dependent. The FAQ was administered by a trained interviewer. Higher scores indicate a greater requirement of assistance.
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Timepoint [23]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
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Secondary outcome [24]
0
0
Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score
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Assessment method [24]
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0
The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening.
Query!
Timepoint [24]
0
0
Baseline, Week 48, Week 96
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Secondary outcome [25]
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0
Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score
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Assessment method [25]
0
0
The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening.
Query!
Timepoint [25]
0
0
Baseline, Week 48, Week 96
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Secondary outcome [26]
0
0
Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score
Query!
Assessment method [26]
0
0
The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening.
Query!
Timepoint [26]
0
0
Baseline, Week 48, Week 96
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Secondary outcome [27]
0
0
Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score
Query!
Assessment method [27]
0
0
The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning (functional abilities). Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening.
Query!
Timepoint [27]
0
0
Baseline, Week 48, Week 96
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Secondary outcome [28]
0
0
Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score
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Assessment method [28]
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0
The UPSA-Brief is a performance-based instrument which uses a series of tasks and roleplay scenarios to evaluate a person's functional capacity in two areas of basic living skills (i.e., financial skills and communication skills). Scores range from 0 to 100; a higher score of the UPSA-Brief is desirable.
Query!
Timepoint [28]
0
0
Baseline, Week 48, Week 96
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Secondary outcome [29]
0
0
Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score
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Assessment method [29]
0
0
The ADCS-MCI-ADL-24 is a 24-item, study partner-based assessment of activities of daily living designed specifically for AD patients and is completed by a trained rater. The scale assesses functional activities such as cooking, household chores, shopping, keeping appointments, social interactions and hobbies. Items are assessed according to whether they were performed in the past 4 weeks and, if so, some items are further assessed as to whether they were performed independently, with supervision, or with physical help. Scores on the ADCS-ADL-MCI range from 0 to 69, where higher score indicates greater capability to carry out activities of daily living.
Query!
Timepoint [29]
0
0
Baseline, Week 48, Week 96
Query!
Secondary outcome [30]
0
0
Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score
Query!
Assessment method [30]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. Total score can range from 40 to 160 with a higher score representing a better outcome.
Query!
Timepoint [30]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [31]
0
0
Change From Baseline Over Time in RBANS - Coding Total Score
Query!
Assessment method [31]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Coding Total Score of the RBANS ranges from 0 to 89, with a higher score representing a better outcome.
Query!
Timepoint [31]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [32]
0
0
Change From Baseline Over Time in RBANS - Digit Span Total Score
Query!
Assessment method [32]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Digit Span Total Score of the RBANS ranges from 0 to 8, with a higher score representing a better outcome.
Query!
Timepoint [32]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [33]
0
0
Change From Baseline Over Time in RBANS - Figure Copy Total Score
Query!
Assessment method [33]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Copy Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome.
Query!
Timepoint [33]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [34]
0
0
Change From Baseline Over Time in RBANS - Figure Recall Total Score
Query!
Assessment method [34]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Recall Total Score of the RBANS ranges from 0 to 18, with a higher score representing a better outcome.
Query!
Timepoint [34]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [35]
0
0
Change From Baseline Over Time in RBANS - List Recognition Total Score
Query!
Assessment method [35]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Recognition Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome.
Query!
Timepoint [35]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [36]
0
0
Change From Baseline Over Time in RBANS - List Learning Total Score
Query!
Assessment method [36]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Learning Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome.
Query!
Timepoint [36]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [37]
0
0
Change From Baseline Over Time in RBANS - Line Orientation Total Score
Query!
Assessment method [37]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Line Orientation Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome.
Query!
Timepoint [37]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [38]
0
0
Change From Baseline Over Time in RBANS - List Recall Total Score
Query!
Assessment method [38]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Recall Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome.
Query!
Timepoint [38]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [39]
0
0
Change From Baseline Over Time in RBANS - Picture Naming Total Score
Query!
Assessment method [39]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Picture Naming Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome.
Query!
Timepoint [39]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [40]
0
0
Change From Baseline Over Time in RBANS - Semantic Fluency Total Score
Query!
Assessment method [40]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Semantic Fluency Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome.
Query!
Timepoint [40]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [41]
0
0
Change From Baseline Over Time in RBANS - Story Memory Total Score
Query!
Assessment method [41]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Story Memory Total Score of the RBANS ranges from 0 to 24, with a higher score representing a better outcome.
Query!
Timepoint [41]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [42]
0
0
Change From Baseline Over Time in RBANS - Story Recall Total Score
Query!
Assessment method [42]
0
0
The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Story Recall Total Score of the RBANS ranges from 0 to 12, with a higher score representing a better outcome.
Query!
Timepoint [42]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [43]
0
0
Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score
Query!
Assessment method [43]
0
0
The MMSE is a brief, 30-point questionnaire, administered by a trained rater, which provides a quantitative measure of cognitive status in adults and is widely used to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time in AD participants. The MMSE ranges from 0 to 30, with lower scores indicating greater impairment.
Query!
Timepoint [43]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [44]
0
0
Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score
Query!
Assessment method [44]
0
0
The NPI is used to assess changes in the participant's behavior that occurred in a defined period of time (4 weeks). The NPI assesses 12 behavioral domains on the dimensions of frequency and severity. Frequency is rated on a scale where 0 = absent, 1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently. Severity is rated on a scale where 0 = absent, 1 = mild, 2 = moderate, 3 = severe. For each of the domains, 3 scores are obtained: frequency, severity, and total (product of frequency and severity; ranges from 0 to 12, with a lower score desirable). A total NPI score can be calculated by summing the domain total scores. Total Score ranges from 0 to 144 with a lower score desirable.
Query!
Timepoint [44]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Secondary outcome [45]
0
0
Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score
Query!
Assessment method [45]
0
0
ADCOMS score is a composite score which is a weighted linear combination of the selected individual scale items from ADAS-Cog-14 (see description in Outcome Measure 10) , MMSE (see description in Outcome Measure 45), and CDR-SB (see description in Outcome Measure 1) scales. The ADCOMS score ranges from 0 to 1.97, with a lower score desirable.
Query!
Timepoint [45]
0
0
Baseline, Week 24, Week 48, Week 72, Week 96
Query!
Eligibility
Key inclusion criteria
- Subject who meets the National Institute on Aging and the Alzheimer's Association
(NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:
- Clinical Dementia Rating (CDR)-Global Score of 0.5
- Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive
- Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory
Index (RBANS - DMI) score of 85 or lower
- Subject has a positive amyloid positron emission tomography (PET) scan.
- Subject has a Modified Hachinski Ischemic Scale (MHIS) score of = 4.
- The subject has an identified, reliable, study partner (e.g., family member).
- If using medications to treat symptoms related to AD, doses must be stable for at
least 12 weeks prior to randomization.
Query!
Minimum age
55
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Subject has any contraindications or inability to tolerate brain magnetic resonance
imaging (MRI), PET scans or lumbar puncture.
- Subject has evidence of any other clinically significant neurological disorder other
than early AD.
- In the opinion of the investigator, the subject has any clinically significant or
uncontrolled medical or psychiatric illness, or has had an infection requiring medical
intervention in the past 30 days.
- Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic
attack or required intervention for any of these conditions within 6 months of
Screening.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
26/01/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/07/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
453
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
The Kinghorn Cancer Centre /ID# 152632 - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Griffith University /ID# 152635 - Southport
Query!
Recruitment hospital [3]
0
0
Austin Health /ID# 152637 - Heidelberg
Query!
Recruitment hospital [4]
0
0
The Royal Melbourne Hospital /ID# 202633 - Parkville
Query!
Recruitment hospital [5]
0
0
Australian Alzheimer's Res Fou /ID# 152634 - Nedlands
Query!
Recruitment hospital [6]
0
0
Neurodegenerative Disorders Research /ID# 152826 - West Perth
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
4222 - Southport
Query!
Recruitment postcode(s) [3]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [4]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [5]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [6]
0
0
6005 - West Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Mississippi
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New Jersey
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New York
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
North Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Oregon
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Pennsylvania
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Rhode Island
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Tennessee
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Texas
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Utah
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Virginia
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Bruxelles-Capitale
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Vlaams-Brabant
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Liege
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Ontario
Query!
Country [26]
0
0
Denmark
Query!
State/province [26]
0
0
Hovedstaden
Query!
Country [27]
0
0
Finland
Query!
State/province [27]
0
0
Varsinais-Suomi
Query!
Country [28]
0
0
Finland
Query!
State/province [28]
0
0
Kuopio
Query!
Country [29]
0
0
Italy
Query!
State/province [29]
0
0
Emilia-Romagna
Query!
Country [30]
0
0
Italy
Query!
State/province [30]
0
0
Lazio
Query!
Country [31]
0
0
Italy
Query!
State/province [31]
0
0
Umbria
Query!
Country [32]
0
0
Italy
Query!
State/province [32]
0
0
Brescia
Query!
Country [33]
0
0
Italy
Query!
State/province [33]
0
0
Milano
Query!
Country [34]
0
0
Italy
Query!
State/province [34]
0
0
Milan
Query!
Country [35]
0
0
Netherlands
Query!
State/province [35]
0
0
Utrecht
Query!
Country [36]
0
0
New Zealand
Query!
State/province [36]
0
0
Burwood
Query!
Country [37]
0
0
Spain
Query!
State/province [37]
0
0
Pais Vasco
Query!
Country [38]
0
0
Spain
Query!
State/province [38]
0
0
Barcelona
Query!
Country [39]
0
0
Spain
Query!
State/province [39]
0
0
Madrid
Query!
Country [40]
0
0
Sweden
Query!
State/province [40]
0
0
Stockholms Lan
Query!
Country [41]
0
0
Sweden
Query!
State/province [41]
0
0
Vastra Gotalands Lan
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study seeks to evaluate the efficacy and safety of ABBV-8E12 in participants with early
Alzheimer's disease (AD).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02880956
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
ABBVIE INC.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02880956
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