CN008-0003
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Global Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Participants with Early Alzheimer’s Disease (TargetTau-1)
IRAS ID
1009662
Contact name
Head of Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb Company
Research summary
Alzheimer’s Disease (AD) is a disease of the brain characterised by symptoms that affect thinking, memory, and the ability to do everyday tasks. These symptoms worsen as the disease moves from early to advanced stages.
CN0080003 is a study to evaluate BMS-986446 in participants with early AD. The study will be including patients who are 50-80 years old and are diagnosed with early AD, which includes both Mild Cognitive Impairment (MCI) due to AD and mild AD dementia. Approximately 475 participants will be randomized in a 4:3:3 ratio to receive placebo (an inactive drug that looks like the real one but has no medicine in it), BMS-986446 1400 mg, or BMS-986446 4200 mg. The study will have 3 phases: a screening period, a treatment period, and a safety follow-up. Study drug (BMS-986446 or placebo) will be administered intravenously (IV) every 4-weeks during the treatment period. Cognitive and clinical assessments will be conducted at baseline, 12-weeks, 24-weeks, 48-weeks, and 76-weeks.
The study will also include an optional sub-study to learn more about how protein levels within the body change in response to the study drug and how these changes affect their memory and learning. This sub-study will assess additional cognitive and clinical assessments throughout the treatment period with a target enrolment of approximately 100 participants.
A safety follow-up visit is required 11 weeks after the last dose of study drug (eg, Week 87) for all participants who do not enter an optional roll-over open-label extension study. The total duration of the study is up to 95 weeks from the date of consent (97 weeks for participants who consent to participate in the optional sub-study).REC name
East of Scotland Research Ethics Service REC 2
REC reference
24/ES/0043
Date of REC Opinion
26 Jul 2024
REC opinion
Further Information Favourable Opinion