Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; Mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or mild AD

• Registration Number: EUCTR2017-002901-37-FR
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-06
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 528

Inclusion Criteria

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
o Objective evidence of cognitive impairment at Screening
o Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD
o Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)
o 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 234
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 294

Exclusion Criteria

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, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified