Pepinemab for Alzheimer's Disease
(SIGNAL-AD Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Vaccinex Inc.

Trial Summary

What is the purpose of this trial?

To investigate safety, tolerability, the effects on cognition and brain metabolism of pepinemab in early AD dementia (early AD) subjects.

Research Team

Eric Siemers, MD

Principal Investigator

Vaccinex Inc.

Eligibility Criteria

This trial is for adults aged 55-85 with early Alzheimer's Disease, evidenced by specific cognitive tests and brain scans. Participants must have a reliable partner to assist them, not be at risk of pregnancy or agree to use birth control, and be in stable health with no recent major illnesses or certain chronic conditions.

Inclusion Criteria

I am a woman who cannot become pregnant.

I have someone close who can attend all trial visits with me.

I meet specific health and cognitive function criteria.

See 3 more

Exclusion Criteria

I have been diagnosed with a neurological condition that affects my thinking.

Body weight greater than 125 kg

I have had cancer within the last 2 years.

See 13 more

Treatment Details

Interventions

Pepinemab (Monoclonal Antibodies)

Trial OverviewThe study is testing the safety and impact on cognition and brain metabolism of a drug called Pepinemab compared to a placebo in people with early-stage Alzheimer's. The goal is to see if this treatment can help manage symptoms better than no active medication.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: pepinemab 40mg/kgExperimental Treatment1 Intervention

The study drug, pepinemab, will be administered via monthly intravenous infusions.

Group II: PlaceboPlacebo Group1 Intervention

.A placebo control will be administered via monthly intravenous infusions.