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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 belowSelect...
I am a woman who cannot become pregnant.
Select...
I am between 55 and 85 years old.
SIGNAL-AD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 40 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 40 weeks
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 moreOther outcome measures
Serum
CSF concentrations of YKL-40
CSF concentrations of tau and p-tau
+10 moreSIGNAL-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.
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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
92 Previous Clinical Trials
40,861 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who cannot become pregnant.I have been diagnosed with a neurological condition that affects my thinking.I have someone close who can attend all trial visits with me.I have had cancer within the last 2 years.I am currently dealing with a serious infection.I meet specific health and cognitive function criteria.I do not have any major health issues unrelated to my current condition.I agree to use birth control during and for 6 months after the study.I am receiving an FDA-approved treatment for Alzheimer's.I am between 55 and 85 years old.I have a significant blood, liver, heart, or kidney condition.Your MMSE score is between 17 and 26.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: pepinemab 40mg/kg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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