Vanderbilt Clinical Trials

Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease

Purpose

The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.

Condition

Alzheimer Disease, Early Onset

Eligibility

Eligible Ages: Between 60 Years and 80 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria. - Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline. - Evidence of AD pathology. - Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II). - Mini Mental Status Examination (MMSE) score ≥ 20 to 28 (inclusive).

Exclusion Criteria

Any evidence of a condition that may affect cognition other than AD. - Contraindications to PET imaging. - Inability to tolerate or contraindication to magnetic resonance imaging. - Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments. - Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Placebo Comparator Placebo		Other: Placebo Specified dose on specified days
Experimental BMS-986446 Dose A		Drug: BMS-986446 Specified dose on specified days
Experimental BMS-986446 Dose B		Drug: BMS-986446 Specified dose on specified days

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37212

Contact:
Lealani Acosta, Site 0222
615-936-0060

More Details

Status: Recruiting
Sponsor: Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.