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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02245737




Registration number
NCT02245737
Ethics application status
Date submitted
18/09/2014
Date registered
22/09/2014

Titles & IDs
Public title
An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease
Scientific title
A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study)
Secondary ID [1] 0 0
I8D-MC-AZES
Secondary ID [2] 0 0
16023
Universal Trial Number (UTN)
Trial acronym
AMARANTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer´s Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lanabecestat
Treatment: Drugs - Placebo

Experimental: Lanabecestat 20 milligrams (mg) - Lanabecestat 20 mg given orally once daily for 104 weeks.

Experimental: Lanabecestat 50 mg - Lanabecestat 50 mg given orally once daily for 104 weeks.

Placebo comparator: Placebo - Placebo given orally once daily for 104 weeks.


Treatment: Drugs: Lanabecestat
Administered orally

Treatment: Drugs: Placebo
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Timepoint [1] 0 0
Baseline, Week 104
Secondary outcome [1] 0 0
Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
Timepoint [1] 0 0
Baseline, Week 104
Secondary outcome [2] 0 0
Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
Timepoint [2] 0 0
Baseline, Week 104
Secondary outcome [3] 0 0
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
Timepoint [3] 0 0
Baseline, Week 104
Secondary outcome [4] 0 0
Change From Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Timepoint [4] 0 0
Baseline, Week 104
Secondary outcome [5] 0 0
Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage
Timepoint [5] 0 0
Baseline through Loss of 1 Global Stage or Week 104
Secondary outcome [6] 0 0
Change From Baseline in Neuropsychiatric Inventory (NPI) Score
Timepoint [6] 0 0
Baseline, Week 104
Secondary outcome [7] 0 0
Change From Baseline on the Mini-Mental State Examination (MMSE)
Timepoint [7] 0 0
Baseline, Week 104
Secondary outcome [8] 0 0
Pharmacodynamics (PD): Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aß)1-42
Timepoint [8] 0 0
Baseline, Week 97
Secondary outcome [9] 0 0
PD: Percent Change From Baseline in Concentration of CSF Biomarker Aß1-40
Timepoint [9] 0 0
Baseline, Week 97
Secondary outcome [10] 0 0
Change From Baseline in CSF Total Tau
Timepoint [10] 0 0
Baseline, Week 97
Secondary outcome [11] 0 0
Change From Baseline in CSF Phosphorylated Tau
Timepoint [11] 0 0
Baseline, Week 97
Secondary outcome [12] 0 0
Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan
Timepoint [12] 0 0
Baseline, Week 104
Secondary outcome [13] 0 0
Change From Baseline in Tau PET ((Flortaucipir F18)
Timepoint [13] 0 0
Baseline, Week 104
Secondary outcome [14] 0 0
Change From Baseline in Brain Metabolism Using Fluorodeoxyglucose (FDG)
Timepoint [14] 0 0
Baseline, Week 104
Secondary outcome [15] 0 0
Change From Baseline in Whole Brain Volume
Timepoint [15] 0 0
Baseline, Week 104
Secondary outcome [16] 0 0
Pharmacokinetics (PK): Plasma Concentration of Lanabecestat
Timepoint [16] 0 0
Week 4, post dose prior to departure from the clinic

Eligibility
Key inclusion criteria
* Gradual and progressive change in the participant's memory function over more than 6 months, reported by participant and study partner
* Mini-Mental State Examination score of 20-30 inclusive at screening
* Objective impairment in memory as evaluated by memory test performed at screening
* For a diagnosis of mild Alzheimer's Disease (AD), participant meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD
* For a diagnosis of MCI due to AD, participant meets NIA-AA criteria for MCI due to AD
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Significant neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson´s disease, or epilepsy or recurrent seizures
* History of clinically evident stroke, or multiple strokes based on history or imaging results
* History of clinically important carotid or vertebrobasilar stenosis or plaque
* History of multiple concussions with sustained cognitive complaints or objective change in neuropsychological function in the last 5 years
* Participants with a current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of Major Depressive Disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study
* History of alcohol or drug abuse or dependence (except nicotine dependence) within 2 years before the screening
* Within 1 year before the screening or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia
* Congenital QT prolongation
* History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer or other cancers with low-risk of recurrence or spread
* Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/10/2018
Sample size
Target
Accrual to date
Final
2218
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Southern Neurology - Kogarah
Recruitment hospital [2] 0 0
Griffith University - Gold Coast
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 0 0
Delmont Private Hospital - Glen Iris
Recruitment hospital [6] 0 0
Heidelberg Repatriation Hospital - Heidelberg
Recruitment hospital [7] 0 0
The Florey Institute of Neuroscience and Mental Health - Parkville
Recruitment hospital [8] 0 0
Australian Alzheimer's Research Foundation - Nedlands
Recruitment hospital [9] 0 0
Neuro Trials Victoria Pty Ltd - Noble Park
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4222 - Gold Coast
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3146 - Glen Iris
Recruitment postcode(s) [6] 0 0
3081 - Heidelberg
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment postcode(s) [9] 0 0
3174 - Noble Park
Recruitment outside Australia
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United States of America
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Romania
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Bucuresti
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Leeds
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Staffordshire
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Brentford
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Glasgow
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London
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02245737