Summary

for people ages 50-80 (full criteria)
at UCLA
study started
estimated completion

Description

Summary

To evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. To evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD. To evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD.

Official Title

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease

Keywords

Alzheimer's Disease Mild cognitive impairment Alzheimer Disease Cognitive Dysfunction BIIB092

Eligibility

For people ages 50-80

Key Inclusion Criteria:

  • Must have a gradual and progressive change in memory function over more than 6 months.
  • Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD and must have
  • Objective evidence of cognitive impairment at Screening
  • Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD
  • Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)
  • CDR Memory Box score of ≥0.5
  • Must consent to apolipoprotein E (ApoE) genotyping
  • Must have 1 informant/study partner
  • Must have amyloid beta positivity confirmed at Screening

Key Exclusion Criteria:

  • Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns
  • Clinically significant, unstable psychiatric illness
  • Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
  • Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
  • History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1
  • Indication of impaired renal or liver function
  • Alcohol or substance abuse in past 1 year
  • Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period
  • Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1.
  • Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant's ability to perform cognitive testing or complete study procedures.
  • Contraindications to study procedures

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • Mary S. Easton Center for Alzheimer's Disease Research, UCLA accepting new patients
    Los Angeles California 90095 United States
  • Neuropain Medical Center accepting new patients
    Fresno California 93710 United States
  • Hoag Memorial Hospital Presbyterian accepting new patients
    Newport Beach California 92663 United States
  • Research Site accepting new patients
    Irvine California 92618 United States
  • Pacific Research Network, Inc accepting new patients
    San Diego California 92103 United States
  • Syrentis Clinical Research accepting new patients
    Santa Ana California 92705 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Biogen
Links
US Residents may click here to find out more about participation in this trial
ID
NCT03352557
Phase
Phase 2
Study Type
Interventional
Last Updated