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Study of an Antibody Treatment for Alzheimer's Disease

Purpose

BIIB037 is an experimental drug being developed by Biogen Idec for the treatment of Alzheimer’s disease and Prodromal Alzheimer’s disease. BIIB073 is a human antibody against the beta amyloid protein that builds up in the plaques in the brain of patients with Alzheimer’s disease. The purpose of this research study is to find out more about the safety of BIIB037. This study is being conducted in groups called treatment arms. The study treatment will be given by intravenous (IV) infusion into a vein in the arm. Study participants will be randomly assigned (like flipping a coin) to receive either BIIB037 or placebo (a placebo looks like the study drug but does not contain active ingredients). Participants have a 75% chance of being assigned to the study treatment. Study treatments will take place once every 4 weeks. This study is 78 weeks long (roughly 1 year and 5 months) and requires roughly 25 visits to UCLA. To be eligible, participants must be between the ages of 55 and 90 and must have a diagnosis of Alzheimer’s disease or mild cognitive impairment. To learn more, please call (310) 794-6039 or send an email to: This email address is being protected from spambots. You need JavaScript enabled to view it. .

Sponsor: Biogen Idec
ClinicalTrials.gov Identifier: NCT01677572

Condition: Intervention: Phase:
Alzheimer's Disease Drug: BIIB037 Phase I

Study Type: Interventional
Study Design: A Randomized, Double-Blinded (Subject, Caregiver, Investigator), Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects with Prodromal or Mild Alzheimer’s Disease.
Lay Title: A Safety study of a human antibody for Alzheimer’s disease and Prodromal Alzheimer’s disease.
Length of Study: 78 Weeks; Study treatments will take place once every 4 weeks.
Number of Visits: 25 visits
Eligibility
Ages Eligible for Study: 55 Years to 90 Years
Genders Eligible for Study: Both
Criteria

Inclusion Criteria:

Subjects must meet criteria for Prodromal AD or Mild AD:
  1. Mini Mental State Examination (MMSE) score between 20-30,
  2. Clinical Dementia Rating Scale (CDR) score of 0.5 or 1, and
  3. a free recall score of lesser or equal to 27 on the Free and Cued Selective Reminding Test (FCSRT) for prodromal AD.
Subjects must have a positive florbetapir PET amyloid scan.
Subjects must consent to APOE genotyping.

Exclusion Criteria:

Any medical or neurological condition (other than AD) that might be a contributing cause of the subject's cognitive impairment.
Have had a stroke or TIA or unexplained loss of consciousness in the past 1 year.
Clinically significant psychatric illness in past 6 months.
Seizure in the past 3 years.
Have human immunodeficiency virus (HIV) infection.
Have a significant systematic illness or infection in past 30 days.
Brain MRI showing evidence of greater than 4 microhemorrhages.
Alcohol or substance abuse in past 1 year.
Taking blood thinners (except for aspirin up to 325mg daily)
Have changes in medications or doses of medication in past 4 weeks.

Contact: Doug Hawkins at (310) 794-6039 or This email address is being protected from spambots. You need JavaScript enabled to view it. to participate in this study or for more information.