PROSPECT-ALZ

A study of LY3372689 to assess the safety, tolerability, and efficacy in participants with Alzheimer's disease

Conditions

Sponsor

Eli Lilly and Company

Phase

Status

Drug

LY3372689

Countries

Poland

A capsule taken orally

Participants will be selected at random to either receive one of the following options:

A capsule of LY3372689 (low dose)
A capsule of LY3372689 (high dose)
A capsule of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).

Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

The purpose of the study is to assess the safety, tolerability and effect of LY3372689 in people with early symptomatic Alzheimer's disease.

Participants will receive LY3372689 or placebo for between 76 and 124 weeks
The maximum total study duration is 131 weeks (around 2.5 years) and include up to 31 visits to the study center.

Further information on the procedures, tests and number of visits can be obtained from the study team.

During the study, participants will be asked to complete a test that will assess cognition and function (this is a test called iADRS)
To complete other tests that will assess their memory, functioning, cognition improvement and activities of daily living (i.e. tests like ADAS-Cog, MMSE, CDR-SB, ADCS-iADL)
Participants will be asked to undertake brain scans (PET, MRI) to see changes in biomarkers in the brain.

To take part in the study, participants must:

Be between 60 and 85 years old
Have gradual and progressive change in memory function reported by participants or study partner for at least six months
Have a score of 0.5 to 1 in the Clinical Dementia Rating-Global Score (CDR) and a score between 22 and 30 in the MMSE test questionnaire test (a test about your memory). This would suggest that the person has an impairment in their memory that is at a very mild stage
Have evidence of abnormal accumulation of amyloid in the brain (determined through PET brain scans)
Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration.

Exclusion criteria include:

Contraindication to brain scans (PET, MRI)
Have known allergies to LY3372689, related compounds, or any components of the formulations
Participants must not have cancer within the last 5 years
Participants must not have history of Hepatitis B or C.

The above list is not exhaustive.