Study Information
AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)
Inclusion Criteria
- Age: 55-80 Inclusive – Those 55-64 must have parent/sibling with Dx prior to 75, confirmed APOE carrier status, or confirmed elevated brain amyloid
- Targets: Pre-Clinical
- AD MEDS: Prohibited
- Clinical Trials: Possibly
- Study Partner: Required for some visits
- Mechanism of Action: Humanized immunoglobulin G1 monoclonal antibody that preferentially binds to Aβ protofibrils.
Exclusion Criteria
- Neurological Disease History: 2 year history of psychiatric diagnosis/symptoms that could interfere with study
- Cancer History: Within 3 years (with exclusions, check w/ SCs)
- Geriatric Depression Scale: N/A
- HIV, HepB or HepC: HIV Excluded
- C-SSRS: Yes to 4, 5 or any suicidal ideation within 6 months of screening, or has been hospitalized/treated for suicidal behavior within 5 years
- Alcohol or Drug Abuse: Known or suspected history within 2 years