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

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

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

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.

Details
Clinical Study IdentifierTX136830
Last Modified on25 March 2021

Eligibility

How to participate?

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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