A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease

JRCT ID: jRCT2031210449

Registered date:24/11/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Alzheimer Disease
• Date of first enrollment: 21/12/2021
• Target sample size: 330
• Countries of recruitment: Australia,Japan,Canada,Japan,Netherlands,Japan,Poland,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

-Drug: LY3372689
given orally
-Drug: Placebo
given orally
<Study Arms>
-Experimental: LY3372689 High Dose
LY3372689 given orally
Intervention: Drug: LY3372689
-Experimental: LY3372689 Low Dose
LY3372689 given orally
Intervention: Drug: LY3372689
-Placebo Comparator: Placebo
Placebo given orally
Intervention: Drug: Placebo

Outcome(s)

Primary Outcome

Change from Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, 76 to 124 Weeks ]
Change from Baseline to End Time Point in iADRS will be measured in participants with early symptomatic Alzheimer's Disease (AD) with demonstrated presence of moderate levels of tau pathology

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude criteria

-Contraindication to MRI or PET scans
-Have known allergies to LY3372689, related compounds, or any components of the formulations

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05063539