Alzheimer’s Disease Trial of Aducanumab

  • Study Director: Adam Boxer, MD, PhD
  • Sponsor: Biogen
  • Recruiting? Yes
  • Official Study Title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects with Early Alzheimer’s Disease
  • ClinicalTrials.gov Identifier: NCT02477800
  • Conditions Studied: Alzheimer’s disease
  • Intervention: Aducanumab (BIB037) and placebo control; aducanumab is administered intravenously (IV) once every four weeks
  • Phase: Phase 3

Purpose of the Study

The primary purpose of this study is to find out whether aducanumab has the potential to slow down disease progression in subjects with early Alzheimer’s disease (AD) by comparing it to placebo and to evaluate its safety (side effects) and to find out more about aducanumab.

Eligibility

Inclusion Criteria:  Subjects must be between 50–85 years of age and meet diagnostic criteria for mild cognitive impairment (MCI) due to AD or mild Alzheimer’s disease. Subjects must also have a Mini Mental State Examination (MMSE) score of 24 through 30 inclusive at the screening visit. Subjects must be willing and able to have brain MRIs, have a florbetapir PET scan consistent with the presence of amyloid pathology at screening and consent to apolipoprotein E (ApoE) genotyping. Subjects must have a reliable informant or caregiver who is willing to complete study-related questionnaires.

Exclusion Criteria: Subjects must not meet diagnostic criteria for another medical or neurological condition (other than Alzheimer’s disease) that might be a contributing cause of the subject’s cognitive impairment. Subjects must also not have a history of stroke or transient ischemic attack (TIA) or unexplained loss of consciousness in the past year, clinically significant psychiatric illness in the past six months, history of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities in the past year, impaired renal or liver function, HIV infection, significant systematic illness or infection in the past 30 days, and any contraindications to MRIs or PET scans. Subjects must not be currently enrolled in another clinical trial.

What to Expect

Testing: Monthly infusions, multiple brain MRIs, at least one PET scan, optional lumbar punctures, neurological and physical examinations, cognitive testing and neuropsychiatric assessments, ECGs, blood and urine specimen collection, vital signs

The Frequency of Visits:

  • Screening phase: 2–3 visits within eight weeks of the first infusion
  • Dose administration in placebo-controlled period: Monthly infusions for 76 weeks
  • Dose administration in open-label extension period: Monthly infusions for 100 weeks
  • Follow-up safety visits: 18 weeks

Materials Needed Before Evaluation: Participants meet criteria for MCI due to AD or mild AD according to NIA-AA criteria (based on Albert 2011McKhann 2011).

Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits, and subjects will be reimbursed up to $100 for each scheduled visit to help defray any incidental expenses incurred in the course of participating in this study.

Contact Information

Coordinator: Avery O’Hara – Avery.OHara@ucsf.edu, 415.476.8333
Clinical Trials Nurse: Mary Koestler, RN, PhD, CCRC – Mary.Koestler@ucsf.edu, 415.476.0661