Study of AV-1959, an Amyloid Beta Vaccine

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Description

Phase 1 clinical trial of AV-1959 amyloid-β vaccine for Alzheimer's disease (AD).

Targeted Conditions

Study Overview

Start Date
February 27, 2023
Completion Date
November 7, 2026
Enrollment
48
Date Posted
December 8, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Banner Alzheimer's Institute
Phoenix, Arizona 85006, United States

Hoag Memorial Hospital
Newport Beach, California 92663, United States

University of South Florida
Tampa, Florida 33613, United States

Alzheimer's Research and Treatment Center
Wellington, Florida 33414, United States

Accel Research
Decatur, Georgia 30033, United States

Global Medical Institutes Princeton Medical Institute
Princeton, New Jersey 08540, United States

Eligibility

Minimum Age (years)
60
Maximum Age (years)
85
Eligibility Criteria
Inclusion Criteria:

Male or female subjects from 60 to 85 years of age.

Mild cognitive impairment (MCI) due to Alzheimer's disease (AD), and must have the following:

Mini-Mental State Examination (MMSE) score from 22 to 30;
Clinical Dementia Rating (CDR) global score of 0.5 or 1.0.
A positive visual Aβ positron emission tomography (PET) scan.

Exclusion Criteria:

Participation in another investigational drug or device study or treated with an investigational drug within 30 days or 5 half-lives, whichever is longer, before dosing.
Prior administration of any amyloid-beta or tau immunotherapy (vaccine, antibody)
Magnetic resonance imaging (MRI) showing evidence of existing safety issues.
Use of immunomodulatory or growth-stimulating factors within 30 days prior to study entry.
Any serious illness requiring systemic treatment and/or hospitalization within 4 weeks prior to study entry.
Any major or unstable illness, including unstable ischemic cardiovascular disease, or require the use of excluded medications.
Subjects with insulin-dependent diabetes.
Subjects with pre-existing autoimmune diseases.
A medical condition that in the opinion of the Investigator might be a contributing cause of cognitive impairment.
History/evidence of severe local or systemic reactions to vaccination or significant allergic reactions.
History of seizure disorder.

Study Contact Info

Study Contact Name
Roman Kniazev; Anahit Ghochikyan, PhD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
Detailed Description
The Phase I study is a randomized, multicenter, double-blind, placebo-controlled study consisting of 3 sequential cohorts to determine the safety and tolerability of AV-1959D at three doses compared to a placebo in patients with early AD
NCTid (if applicable)
NCT05642429