A Phase 2 Study of an Anti-MTBR Tau Monoclonal Antibody in Participants with Early Alzheimer's Disease

JRCT ID: jRCT2051240052

Registered date:07/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Early Alzheimer's disease
• Date of first enrollment: 01/07/2024
• Target sample size: 475
• Countries of recruitment: Australia,Japan,Belgium,Japan,Canada,Japan,Denmark,Japan,France,Japan,Poland,Japan,Netherlands,Japan,Shingapore,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,UK,Japan,USA,Japan
• Study type: Interventional

Intervention(s)

Experimental: BMS-986446 Dose A, Specified dose on specified days
Experimental: BMS-986446 Dose B, Specified dose on specified days
Placebo

Outcome(s)

• Primary Outcome: Mean change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score at week 76

Secondary Outcome

-Mean change from baseline in brain tau deposition as measured by tau positron emission tomography (PET) at week 76
-Mean change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score at week 76
-Mean change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score at week 76
-Mean change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score at week 76
-Mean change from baseline in Mini Mental State Examination (MMSE) score at week 76

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 80age old
• Gender: Both

Include 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 >= 22 to 30 (inclusive).

Exclude 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.

Related Information

• Primary Sponsor: Kahl Anja
• Secondary ID(s): NCT06268886