Last updated on April 2013

A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease


Brief description of study

A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease

Detailed Study Description

Patient Inclusion Criteria:

  • Ages: over 55-90
  • Male/Female
  • 12 Month Long Clinical Trial
  • MMSE score 24-30/20-26
  • Subjects must meet criteria for Prodromal AD or Mild AD:
    • Mini Mental State Examination (MMSE) score between 20-30
    • Clinical Dementia Rating Scale (CDR) score of 0.5 or 1
    • 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.

Patient 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.

Clinical Study Identifier: TX136830

Find a site near you

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Axiom Clinical Research of Florida

2919 Swann Ave, Suite 105A Tampa, FL USA
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Recruitment Status: Open


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