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Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT03352557•Biogen

View on ClinicalTrials.gov

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 with mild AD. The secondary objectives of the placebo-controlled period are 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, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD. The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

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

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.
+1 more criteria

Locations (101)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Xenoscience Inc

Phoenix, Arizona, United States

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Dignity Health

Phoenix, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

Advanced Research Center, Inc.

Anaheim, California, United States

The Research Center of Southern California

Carlsbad, California, United States

Positron Research International

Fremont, California, United States

Neuropain Medical Center

Fresno, California, United States

V Royter, MD, APMC

Hanford, California, United States

Key Dates

Start Date

May 3, 2018

Primary Completion Date

August 30, 2021

Completion Date

August 30, 2021

Last Updated

November 8, 2022

Enrollment

654

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

BIIB092

DRUG

Placebo

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

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Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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