Pepinemab for Early-Stage Alzheimer's Disease

What Is This Study About?

This Phase 1/2 study will assess the safety and effects of the experimental drug pepinemab, a monoclonal antibody treatment designed to improve memory, in older adults with early-stage Alzheimer's. Participants will be randomly assigned to receive either the study drug or a placebo by IV infusion once a month for one year. Throughout the trial, participants will undergo PET and MRI brain imaging, complete memory tests, and provide blood and spinal fluid samples. Researchers will monitor all participants for safety and any side effects throughout the trial and one month after the last treatment.

Do I Qualify To Participate in This Study?

Must have:

• Diagnosis of probable Alzheimer's with:
  • Global Clinical Dementia Rating of 0.5 or 1.0
  • Mini-Mental State Examination score of 17 to 26
• Must have either:
  • Positive amyloid PET scan before starting study
  • Positive amyloid cerebrospinal fluid test result before or at the study screening
• Availability of a study partner who has a close relationship with the participant and frequent in-person contact (> 3 times per week, for a minimum of 10 waking hours total per week)
• Female participants must be postmenopausal or surgically sterile
• Male participants must commit to a reliable method of birth control during the study and for six months after the last dose of the study drug
• Adequate vision, hearing, and physical function to complete study tests
• If taking medications for Alzheimer's, dosage must be stable for at least two months prior to the study screening visit
• If taking medication to manage heart rate or blood pressure, dosage must be stable for at least two months prior to the study screening visit
• Overall good physical health over the last six months, based on medical history and study screening evaluation

Must NOT have:

• Participation in another clinical trial for an experimental drug or medical device within one month prior to study screening; if experimental drug was an antibody therapeutic, must wait 180 days from the last treatment or long enough for the therapeutic to clear the body
• Known allergy to any ingredient in the study drug formulation
• Body weight greater than 275 pounds
• Serious risk of suicide or suicide attempt in the past year
• History of substance abuse within one year prior to study screening
• Treatment with any FDA accelerated approval therapy for treatment of Alzheimer's
• Any unstable or uncontrolled medical illness or condition that could interfere with the study, including: 
  • Serious infection, including a history of human immunodeficiency virus or acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection at study screening
  • Serious blood, liver, heart, or kidney disease
  • Malignant cancer within two years of study screening (non-melanoma skin cancers, superficial bladder and prostate cancers are allowed)
• Diagnosis of a neurological condition causing cognitive impairment other than Alzheimer's, such as:
  • Non-Alzheimer's dementia (e.g., Lewy body dementia, frontotemporal dementia)
  • Psychiatric conditions that could cause cognitive impairment (e.g., schizophrenia)
  • History of frequent concussions
• Any serious medical, laboratory, or behavioral abnormality at study screening, including:
  • Electrocardiogram abnormalities
  • MRI brain scan findings that indicate stroke, tumor, tangled blood vessels, swelling
• Any condition that could make undergoing an MRI or PET brain scan unsafe, including:
  • Claustrophobia or inability to lie on scanner bed for 45 minutes
  • Poor vein access
  • Metal shrapnel, pacemaker, presence of metal objects in eyes, skin, or heart
  • Body size and shape that prevents a comfortable fit in scanners
  • Prior radiation exposure that, when combined with study PET scan, would exceed radiation limits
• If undergoing a spinal tap, must not have:
  • Untreated bleeding or clotting disorders
  • Skin infections near spinal tap location
  • Increased brain pressure
  • Serious spinal injury
  • Allergies to numbing medications
  • Taking any of the following anticoagulant medications: coumarins and indandiones, Factor Xa inhibitors, heparins, or thrombin inhibitors

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

California
Pacific Research Network, Inc San Diego, CA 92103 Recruiting Stephen Thein, MD
District of Columbia
Georgetown University Washington, DC 20057 Recruiting
Florida
Brain Matters Research Delray Beach, FL 33445 Recruiting Paayal Patel, MD
Neuropsychiatric Research Center of Southwest Florida Fort Myers, FL 33912 Recruiting Melissa Schaerf
JEM Research Institute Lake Worth, FL 33462 Recruiting Elizabeth Sheldon, NP
Premiere Research Institute of Palm Beach, Neurology Palm Beach, FL 33480 Recruiting
Brain Matters Research Stuart, FL 34997 Recruiting Paayel Patel, MD
Indiana
Indiana University School of Medicine Indianapolis, IN 46202 Recruiting Kala Hall
Kansas
University of Kansas Medical Center Fairway, KS 66205 Recruiting Rebecca Bothwell
New York
Neurological Associates of Albany Albany, NY 12212 Recruiting Richard Holub, MD
Dent Neurological Associates Amherst, NY 14226 Recruiting Horacio Capote, MD
Columbia University Irving Medical Center New York, NY 10032 Recruiting Lawrence Honing, MD
University of Rochester Medical Center Rochester, NY 14620 Recruiting Susan Salem-Spencer
Virginia
Re-Cognition Health Fairfax, VA 22031 Recruiting Monica Bland

Who Sponsors This Study?

Lead: Vaccinex Inc.

Collaborator Sponsor

• Alzheimer's Drug Discovery Foundation
• Alzheimer's Association

Source: ClinicalTrials.gov ID: NCT04381468