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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/NCT04437511
Registration number
NCT04437511
Ethics application status
Date submitted
17/06/2020
Date registered
18/06/2020
Date last updated
29/05/2024
Titles & IDs
Public title
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
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Scientific title
Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
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Secondary ID [1]
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I5T-MC-AACI
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Secondary ID [2]
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17737
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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 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
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Description of intervention(s) / exposure
Treatment: Drugs - Donanemab
Treatment: Drugs - Placebo
Experimental: Donanemab - Participants received 700 milligram (mg) Donanemab every 4 weeks (Q4W) x 3 doses, then 1400 mg Q4W given intravenously (IV) for up to 72 weeks
Placebo Comparator: Placebo - Participants received placebo given IV.
Treatment: Drugs: Donanemab
Given IV
Treatment: Drugs: Placebo
Given IV
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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 on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)
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Assessment method [1]
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Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the ADAS-Cog13 and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. Least Squares (LS) Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline acetylcholinesterase inhibitor (AchI)/Memantine use.
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Timepoint [1]
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Baseline, Week 76
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Primary outcome [2]
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Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)
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Assessment method [2]
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Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
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Timepoint [2]
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Baseline, Week 76
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Secondary outcome [1]
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Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population)
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Assessment method [1]
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MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use.
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Timepoint [1]
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Baseline, Week 76
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Secondary outcome [2]
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Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population)
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Assessment method [2]
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MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
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Timepoint [2]
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Baseline, Week 76
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Secondary outcome [3]
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Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)
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Assessment method [3]
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The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use.
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Timepoint [3]
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Baseline, Week 76
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Secondary outcome [4]
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Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)
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Assessment method [4]
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The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-cog consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
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Timepoint [4]
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Baseline, Week 76
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Secondary outcome [5]
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Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Overall Population)
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Assessment method [5]
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CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, age at baseline, baseline tau category, pooled investigator, and baseline AchI/Memantine use.
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Timepoint [5]
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Baseline, Week 76
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Secondary outcome [6]
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Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population)
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Assessment method [6]
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CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, age at baseline, pooled investigator, and baseline AchI/Memantine use.
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Timepoint [6]
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Baseline, Week 76
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Secondary outcome [7]
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Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Overall Population)
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Assessment method [7]
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The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use.
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Timepoint [7]
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Baseline, Week 76
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Secondary outcome [8]
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Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Intermediate (Low-medium) Tau Population)
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Assessment method [8]
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The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
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Timepoint [8]
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Baseline, Week 76
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Secondary outcome [9]
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Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Amyloid Positron Emission Tomography (PET) Scan
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Assessment method [9]
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Amyloid PET scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in amyloid plaques. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical brain regions relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, baseline tau category, and age at baseline.
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Timepoint [9]
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Baseline, Week 76
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Secondary outcome [10]
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Change From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
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Assessment method [10]
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Flortaucipir PET imaging was used as a quantitative tau biomarker. Tau PET scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in aggregated tau neurofibrillary tangles (NFTs). Quantitative tau burden was formalized using Standardized Uptake Value Ratio (SUVR) in frontal lobe relative to the cerebellum gray as a reference region. Larger SUVR reflects larger tau burden in the frontal lobe relative to cerebellum gray. LS Mean value was adjusted for baseline score, screening tau category, age and treatment (Type III sum of squares).
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Timepoint [10]
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Baseline, Week 76
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Secondary outcome [11]
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Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
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Assessment method [11]
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MRI scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in brain volume. Volumetric MRI parameters were measured in bilateral hippocampus, bilateral whole brain, and bilateral ventricles. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline tau category, and age at baseline.
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Timepoint [11]
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Baseline, Week 76
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Secondary outcome [12]
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Pharmacokinetics (PK): Average Serum Concentration at Steady State of Donanemab
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Assessment method [12]
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The average serum concentration at steady state, calculated as Cav = AUCtau/tau, where tau is the dosing interval (4 weeks). AUCtau/tau was assessed at week 12, 16, 24, 36, 52, 64 and Cav for the dosing interval from week 16 to week 20 is reported.
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Timepoint [12]
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Week 16 to week 20
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Secondary outcome [13]
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Number or Participants With Anti-Donanemab Antibodies
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Assessment method [13]
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Number of participants with treatment-emergent positive Anti-Donanemab antibodies was summarized by treatment group.
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Timepoint [13]
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Baseline through Week 76
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Eligibility
Key inclusion criteria
- Gradual and progressive change in memory function reported by participants or
informants for = 6 months
- MMSE score of 20 to 28 (inclusive) at baseline
- Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety
cohort
- Meet 18F florbetapir PET scan (central read) criteria
- Have a study partner who will provide written informed consent to participate
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Minimum age
60
Years
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Contraindication to MRI or PET scans
- Current treatment with immunoglobulin G (IgG) therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
22/08/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
1736
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Central Coast Neurosciences Research - Erina
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St Vincent's Hospital - Sydney
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HammondCare Greenwich Hospital - Sydney
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KARA Institute for Neurological Diseases - Sydney
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NeuroCentrix - Carlton
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Delmont Private Hospital - Glen Iris
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HammondCare - Malvern
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Recruitment hospital [8]
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The Alfred Hospital - Melbourne
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Recruitment hospital [9]
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The Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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2250 - Erina
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Recruitment postcode(s) [2]
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2010 - Sydney
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2065 - Sydney
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2113 - Sydney
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3053 - Carlton
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3146 - Glen Iris
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Recruitment postcode(s) [7]
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3144 - Malvern
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Recruitment postcode(s) [8]
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3004 - Melbourne
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Recruitment postcode(s) [9]
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3050 - Parkville
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Recruitment outside Australia
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Bayamon
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Birmingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
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Summary
Brief summary
The reason for this study is to see how safe and effective the study drug donanemab is in
participants with early Alzheimer's disease.
Additional participants will be enrolled to an addendum safety cohort. The participants will
be administered open-label donanemab.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04437511
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Contacts
Principal investigator
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Eli Lilly and Company
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04437511
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