Assessment of Safety, Tolerability, and Efficacy of (LY3372689) in Participants With Alzheimer’s Disease
- Conditions
- Alzheimer DiseaseMedDRA version: 20.0Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2021-000170-29-PL
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 340
•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 PET scan (central analysis) criteria
•Have a study partner who will provide written informed consent to participate
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 316
•Contraindication to MRI or PET scans
•Have known allergies to LY3372689, related compounds, or any components of the formulations
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To assess the effect of LY3372689 vs. placebo on clinical progression in participants with early symptomatic AD with demonstrated presence of moderate levels of tau pathology<br>;Secondary Objective: 1. To assess the effect of LY3372689 vs. placebo on clinical progression in full study population (moderate + highc levels of tau pathology) with<br>early symptomatic AD<br>2. To assess the effect of LY3372689 vs. placebo on clinical progression in full study population and moderate tau sub population with early symptomatic AD<br>3. To assess the effect of LY3372689 vs. placebo on brain region volumes<br>4. To assess the effect of LY3372689 vs. placebo on tau pathology biomarkers <br>5. To assess the PK of LY3372689<br>;Primary end point(s): iADRS change from baseline through end time point;Timepoint(s) of evaluation of this end point: 76-124 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): iADRS change from baseline through end time point;Timepoint(s) of evaluation of this end point: 76-124 weeks<br>