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Monoclonal Antibodies

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

Phase 1 & 2
Waitlist Available
Research Sponsored by Vaccinex Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If female, not of childbearing potential as indicated by specific criteria
Male and female participants between the ages of 55 to 85 (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 40 weeks
Awards & highlights

SIGNAL-AD Trial Summary

This trial is testing a new drug for Alzheimer's disease to see if it is safe, tolerated, and effective.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While the trial primarily aims to assess safety, potential side effects may include allergic reactions due to ingredients in Pepinemab, as well as any common adverse effects associated with new medications being tested for cognitive disorders.

SIGNAL-AD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman who cannot become pregnant.
Select...
I am between 55 and 85 years old.

SIGNAL-AD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 40 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 40 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with treatment emergent adverse events (TEAEs)
Secondary outcome measures
Alzheimer's Disease Assessment Scale- Cognitive subscale (ADAS-cog13)
Alzheimer's Disease
Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC)
+5 more
Other outcome measures
Serum
CSF concentrations of YKL-40
CSF concentrations of tau and p-tau
+10 more

SIGNAL-AD Trial Design

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.

Find a Location

Who is running the clinical trial?

Vaccinex Inc.Lead Sponsor
11 Previous Clinical Trials
703 Total Patients Enrolled
Alzheimer's Drug Discovery FoundationOTHER
21 Previous Clinical Trials
3,091 Total Patients Enrolled
Alzheimer's AssociationOTHER
89 Previous Clinical Trials
40,713 Total Patients Enrolled

Media Library

Pepinemab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04381468 — Phase 1 & 2
Alzheimer's Disease Research Study Groups: Placebo, pepinemab 40mg/kg
Alzheimer's Disease Clinical Trial 2023: Pepinemab Highlights & Side Effects. Trial Name: NCT04381468 — Phase 1 & 2
Pepinemab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04381468 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many facilities are currently overseeing this research?

"The trial is presently running in 14 different sites, such as Premiere Research Institute of Palm Beach, Neurology in Palm Beach and Albany's Neurological Associates. Dent Neurological Associates also has a presence at Amherst alongside the other participating medical centres."

Answered by AI

Am I eligible to be involved in this research initiative?

"Patients with Alzheimer's disease, aged 55 to 85, are eligible for this medical trial which seeks a total of 40 participants."

Answered by AI

Have there been other investigations with regard to the efficacy of Pepinemab?

"Currently, 6 separate trials are being conducted to research the efficacy of Pepinemab. None of these studies have advanced to Phase 3 yet. While most investigations center in Saint Louis, Missouri, there exist 61 distinct clinical sites studying this medication."

Answered by AI

Are recruitment efforts still ongoing for this trial?

"According to the clinicaltrials.gov website, this medical trial is presently looking for volunteers. The initial posting of the study was on July 22nd 2021 and it has since been revised as recently as October 6th 2022."

Answered by AI

What is the current count of participants for this medical experiment?

"The medical trial necessitates the enrollment of 40 eligible patients, who can join either at Premiere Research Institute in Palm Beach or Neurological Associates in Albany."

Answered by AI

Is this clinical trial restricted to those under the age of 75?

"As stipulated in the inclusion criteria, potential participants of this clinical trial must be between 55 and 85 years old. Currently there are 24 studies involving patients under 18 and 541 trials with elderly individuals as their primary cohort."

Answered by AI

Who else is applying?

What site did they apply to?
Indiana University School of Medicine
Columbia University Irving Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have been living with a brain tumor, Pilocystic Astrocytoma since 1994.
PatientReceived 2+ prior treatments
Recent research and studies
~14 spots leftby Mar 2025