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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02972658




Registration number
NCT02972658
Ethics application status
Date submitted
21/11/2016
Date registered
23/11/2016

Titles & IDs
Public title
A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia
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)
Secondary ID [1] 0 0
I8D-MC-AZFD
Secondary ID [2] 0 0
16557
Universal Trial Number (UTN)
Trial acronym
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

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

Outcomes
Primary outcome [1] 0 0
Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Timepoint [1] 0 0
AZES Baseline through AZFD Week 26
Secondary outcome [1] 0 0
Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
Timepoint [1] 0 0
AZES Baseline through AZFD Week 26
Secondary outcome [2] 0 0
Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
Timepoint [2] 0 0
AZES Baseline through AZFD Week 26
Secondary outcome [3] 0 0
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
Timepoint [3] 0 0
AZES Baseline through AZFD Week 26
Secondary outcome [4] 0 0
Change From Baseline on the Mini-Mental Status Examination (MMSE)
Timepoint [4] 0 0
AZES Baseline through AZFD Week 26
Secondary outcome [5] 0 0
Change From Baseline Analysis on the ADAS-Cog13
Timepoint [5] 0 0
AZES Baseline through AZFD Week 52

Eligibility
Key inclusion criteria
* Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed-start I8D-MC-AZFD.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.

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 3
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
15/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/10/2018
Sample size
Target
Accrual to date
Final
421
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Southern Neurology - Kogarah
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Eastern Clinical Research Unit - Box Hill
Recruitment hospital [4] 0 0
Delmont Private Hospital - Glen Iris
Recruitment hospital [5] 0 0
The Florey Institute of Neuroscience and Mental Health - Parkville
Recruitment hospital [6] 0 0
Australian Alzheimer's Research Foundation - Nedlands
Recruitment hospital [7] 0 0
Neuro Trials Victoria Pty Ltd - Noble Park
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3146 - Glen Iris
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
3174 - Noble Park
Recruitment outside Australia
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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/NCT02972658