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.

Vaccinex’s approach is to potentially reprogram the underlying disease pathology that is driven by neuroinflammation with concomitant loss of normal important support functions of glial cells, such as astrocytes and microglia.

Vaccinex’s drug, pepinemab, has previously been tested in individuals with Huntington’s disease, another devastating neurodegenerative disease with symptoms including cognitive impairment.

Trial Details

About the Trial

This is a randomized double-blind, placebo-controlled, parallel-group study of pepinemab in early AD dementia defined as MCI and mild Alzheimer’s dementia. The study is 40 weeks in duration, including a safety and efficacy evaluation 4 weeks after the last dose of study drug. Subjects will be randomized to receive either pepinemab or placebo every 4 weeks by intravenous infusion. The primary objective is the safety and tolerability of study drug. Key secondary objectives are change in cognition determined by CDR-SB and ADAS-cog13 as well as effects on brain metabolism as assessed by [18F] fluorodeoxyglucose (FDG)-PET in the resting state.

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

Age(s)

55 to 85

Condition(s)

Alzheimer Disease
(MMSE range 17-26)

Gender(s)

All

Trial Design

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Trial Locations

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