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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/NCT02972658
Registration number
NCT02972658
Ethics application status
Date submitted
21/11/2016
Date registered
23/11/2016
Date last updated
3/12/2019
Titles & IDs
Public title
A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia
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Scientific title
A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)
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Secondary ID [1]
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I8D-MC-AZFD
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Secondary ID [2]
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16557
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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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0
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Alzheimer's disease
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Neurological
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0
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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 - Lanabecestat
Experimental: AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mg - Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
Experimental: AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg - Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
Experimental: AZES Placebo/AZFD Lanabecestat 20 mg - Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
Experimental: AZES Placebo/AZFD Lanabecestat 50 mg - Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
Treatment: Drugs: Lanabecestat
Administered orally
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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 Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
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Assessment method [1]
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ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.
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Timepoint [1]
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AZES Baseline through AZFD Week 26
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Secondary outcome [1]
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Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
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Assessment method [1]
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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 of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
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Timepoint [1]
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AZES Baseline through AZFD Week 26
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Secondary outcome [2]
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Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
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Assessment method [2]
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FAQ is a 10-item, caregiver-questionnaire and was administered to the study partner and asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now =1; Never did but could do now =0; Normal =0; Has difficulty but does by self =1; Requires assistance =2; Dependent =3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
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Timepoint [2]
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AZES Baseline through AZFD Week 26
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Secondary outcome [3]
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Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
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Assessment method [3]
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The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
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Timepoint [3]
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AZES Baseline through AZFD Week 26
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Secondary outcome [4]
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Change From Baseline on the Mini-Mental Status Examination (MMSE)
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Assessment method [4]
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The MMSE is an instrument used to assess a participant's cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
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Timepoint [4]
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AZES Baseline through AZFD Week 26
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Secondary outcome [5]
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Change From Baseline Analysis on the ADAS-Cog13
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Assessment method [5]
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ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
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Timepoint [5]
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AZES Baseline through AZFD Week 52
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Eligibility
Key inclusion criteria
- Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility
criteria for delayed-start I8D-MC-AZFD.
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Minimum age
55
Years
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Maximum age
No limit
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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
- Participants who participate in AMARANTH (NCT02245737) who develop new conditions
precluding them from enrolling into I8D-MC-AZFD.
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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 administering 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
Terminated
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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
15/03/2017
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
2/10/2018
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Sample size
Target
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Accrual to date
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Final
421
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Southern Neurology - Kogarah
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Royal Adelaide Hospital - Adelaide
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Eastern Clinical Research Unit - Box Hill
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Delmont Private Hospital - Glen Iris
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The Florey Institute of Neuroscience and Mental Health - Parkville
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Australian Alzheimer's Research Foundation - Nedlands
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Neuro Trials Victoria Pty Ltd - Noble Park
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2217 - Kogarah
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5000 - Adelaide
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3128 - Box Hill
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3146 - Glen Iris
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3052 - Parkville
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6009 - Nedlands
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3174 - Noble Park
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Eli Lilly and Company
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Ethics approval
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Summary
Brief summary
This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The
purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in
participants with early Alzheimer's disease dementia at the time of entry into study
I8D-MC-AZES.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02972658
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02972658
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