Study of AV-1959, an Amyloid Beta Vaccine

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

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.