Clinical Trial Evaluating the Safety and Efficacy of Pepinemab in Patients with Alzheimer’s Disease

What is Alzheimer’s Disease?

Alzheimer’s is a progressive brain disease that leads to dementia and affects memory, thinking and behavior. Symptoms eventually become severe enough to interfere with daily tasks. Alzheimer’s is not just a normal part of aging, although the majority of people with Alzheimer’s are 65 and older. Risk factors such as aging, genetics, and lifestyle, can lead to destructive processes to the cells in the brain, including neurons and the cells that support the neurons, called glial cells. This damage can induce inflammation and interfere with the ability of glial cells to perform normal functions, such as supplying energy to the brain.

There is currently no cure for Alzheimer’s Disease. Therapies that treat the underlying disease process and reduce inflammation hold promise to slow the worsening of dementia symptoms and improve quality of life for those with Alzheimer’s and their caregivers.

Trial Purpose

The purpose of the study is to investigate safety, tolerability, the effects on cognition and brain metabolism of pepinemab in people with early AD dementia (early AD). The primary hypothesis being tested is whether pepinemab will be safe and provide benefits in clinical assessments of cognition and in brain metabolism as measured by FDG-PET.

Trial Details

About the Trial

All patients who enroll in the trial will receive treatment once each month by intravenous infusion.

Phase

Phase 1b/Phase 2

Dates

Actual Study Start Date
July 22, 2021

Estimated Primary Completion Date
December 31, 2023

Estimated Study Completion Date
December 31, 2023

Sponsor

Vaccinex, Inc.

Collaborators

Alzheimer’s Drug Discovery Foundation
Alzheimer’s Association

Products

pepinemab
placebo

 

Trial Locations

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Age(s)

55 to 85

Condition(s)

Alzheimer Disease
(MMSE range 17-26)

Gender(s)

All