Trailblazer I5T-MC-AACV | Clinical Research Studies Listing

Recruiting

55 years - 85 years

All

Phase 2

3 participants needed

1 Location

Brief description of study

To assess the effect of donanemab versus placebo on cognitive and functional progression in participants with established alpha-synuclein and amyloid co-pathology

Detailed description of study

Researchers believe that the investigational medicine, a type of medicine called an antibody that targets amyloid plaques in the brain, might help treat the disease. The investigational medicine, Donanemab, is an IgG1 monoclonal antibody that works by binding to these plaques and helping to remove them, potentially slowing down cognitive decline. This study will check if the investigational medicine is safe and works well for people with early memory problems and at least one clinical feature of dementia with Lewy bodies and evidence of alpha-synuclein and amyloid beta in the brain.

The main goal is to see if it can slow down memory and thinking problems over 1 year. Researchers will look at changes in memory and daily activities using tests in the clinic.

This study will last for about 1 year and 6 months.

This is a randomized double blind, placebo-controlled study.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Early Cognitive decline
Age: 55 years - 85 years
Gender: All

Inclusion
• Have gradual cognitive decline,
noticed by yourself or somebody
close to you
• Have a diagnosis that shows at least
one clinical feature of the presence
of dementia with Lewy-bodies
• Have markers of amyloid and alphasynuclein
found in blood and CSF
that meet the study inclusion
• Have a reliable study partner

Updated on 10 Aug 2026. Study ID: 26-7027

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