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