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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05063539




Registration number
NCT05063539
Ethics application status
Date submitted
14/09/2021
Date registered
1/10/2021

Titles & IDs
Public title
A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease
Scientific title
Assessment of Safety, Tolerability, and Efficacy of LY3372689 in Early Symptomatic Alzheimer's Disease
Secondary ID [1] 0 0
I9X-MC-MTAE
Secondary ID [2] 0 0
18094
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer 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 - LY3372689
Treatment: Drugs - LY3372689
Treatment: Drugs - Placebo

Experimental: LY3372689 High Dose - LY3372689 given orally

Experimental: LY3372689 Low Dose - LY3372689 given orally

Placebo comparator: Placebo - Placebo given orally


Treatment: Drugs: LY3372689
given orally

Treatment: Drugs: LY3372689
given orally

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

Outcomes
Primary outcome [1] 0 0
Change from Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS)
Timepoint [1] 0 0
Baseline, 76 to 124 Weeks
Secondary outcome [1] 0 0
Change from Baseline to End Time Point in iADRS
Timepoint [1] 0 0
Baseline, 76 to 124 Weeks
Secondary outcome [2] 0 0
Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Timepoint [2] 0 0
Baseline, 76 to 124 Weeks
Secondary outcome [3] 0 0
Change from Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Timepoint [3] 0 0
Baseline, 76 to 124 Weeks
Secondary outcome [4] 0 0
Change from Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL)
Timepoint [4] 0 0
Baseline, 76 to 124 Weeks
Secondary outcome [5] 0 0
Change from Baseline to End Time Point in Mini Mental State Examination (MMSE)
Timepoint [5] 0 0
Baseline, 76 to 124 Weeks
Secondary outcome [6] 0 0
Change from Baseline to End Time Point in Brain Tau Deposition as Measured by Flortaucipir F18 PET scan
Timepoint [6] 0 0
Baseline, 76 to 124 Weeks
Secondary outcome [7] 0 0
Change from Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures
Timepoint [7] 0 0
Baseline, 76 to 124 Weeks
Secondary outcome [8] 0 0
Pharmacokinetics (PK) Plasma Concentration of LY3372689
Timepoint [8] 0 0
Up to 124 Weeks

Eligibility
Key inclusion criteria
* Gradual and progressive change in memory function reported by participants or informants for = 6 months
* MMSE score of 22 to 30 (inclusive) at baseline
* CDR global score of 0.5 to 1.0 (inclusive), with a memory box score =0.5.
* Meet 18F flortaucipir positron emission tomography (PET) scan (central analysis) criteria
* Have a study partner who will provide written informed consent to participate
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindication to MRI or PET scans
* Have known allergies to LY3372689, related compounds, or any components of the formulations

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
330
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Central Coast Neurosciences Research (Tumbi Umbi) - Central Coast
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Sydney
Recruitment hospital [3] 0 0
HammondCare Greenwich Hospital - Sydney
Recruitment hospital [4] 0 0
Hornsby Ku-Ring-Gai Hospital - Sydney
Recruitment hospital [5] 0 0
KARA Institute for Neurological Diseases - Sydney
Recruitment hospital [6] 0 0
Private Practice - Dr PL Morris - Southport
Recruitment hospital [7] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [8] 0 0
Box Hill Hospital Outpatients - Box Hill
Recruitment hospital [9] 0 0
Delmont Private Hospital - Glen Iris
Recruitment hospital [10] 0 0
HammondCare - Malvern
Recruitment hospital [11] 0 0
NeuroCentrix - Noble Park
Recruitment postcode(s) [1] 0 0
2261 - Central Coast
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2065 - Sydney
Recruitment postcode(s) [4] 0 0
2077 - Sydney
Recruitment postcode(s) [5] 0 0
2113 - Sydney
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
5011 - Woodville
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3146 - Glen Iris
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment postcode(s) [11] 0 0
3174 - Noble Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Rhode Island
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Vermont
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Japan
State/province [14] 0 0
Aichi
Country [15] 0 0
Japan
State/province [15] 0 0
Hyogo
Country [16] 0 0
Japan
State/province [16] 0 0
Ibaraki
Country [17] 0 0
Japan
State/province [17] 0 0
Okayama
Country [18] 0 0
Japan
State/province [18] 0 0
Tokyo
Country [19] 0 0
Japan
State/province [19] 0 0
Yufu
Country [20] 0 0
Poland
State/province [20] 0 0
Dolnoslaskie
Country [21] 0 0
Poland
State/province [21] 0 0
Kujawsko-pomorskie
Country [22] 0 0
Poland
State/province [22] 0 0
Mazowieckie
Country [23] 0 0
Poland
State/province [23] 0 0
Malopolskie
Country [24] 0 0
Poland
State/province [24] 0 0
Podlaskie
Country [25] 0 0
Poland
State/province [25] 0 0
Pomorskie
Country [26] 0 0
Poland
State/province [26] 0 0
Wielkopolskie
Country [27] 0 0
Poland
State/province [27] 0 0
Zachodniopomorskie

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

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 European Union (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: http://www.vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05063539