Status:
TERMINATED
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
Lead Sponsor:
Biogen
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief Summary
The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or wit...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
May 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
654 Patients enrolled
Trial Details
Trial ID
NCT03352557
Start Date
May 3 2018
End Date
August 30 2021
Last Update
November 8 2022
Active Locations (101)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
2
Xenoscience Inc
Phoenix, Arizona, United States, 85004
3
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
4
Dignity Health
Phoenix, Arizona, United States, 85013