Agitation, Alzheimer Disease
Conditions
Brief summary
This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.
Interventions
DRUGBMS-986368
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. * The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation. * History of agitation with onset at least four weeks prior to Screening. * MMSE-1 score ≤24. * NPI-NH agitation/aggression sub-score ≥ 4. * Stable living environment for at least 6 weeks prior to Screening. Participants are eligible if they are in nursing homes, assisted living facilities, or living at home and have an identified study partner (caregiver). * Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable.
Exclusion criteria
* Clinically significant delusions/hallucinations requiring hospitalization. * History of bipolar disorder, schizophrenia, or schizoaffective disorder. * History of major depressive episode with psychotic features during the 12 months prior to Screening. * History of delirium within 30 days of Screening. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline | Up to Week 8 | The CMAI is a scale administered by qualified rater based on caregiver's input on 29 items that assess the frequency of manifestations of agitated behaviors in older adults. Each item is rated on a 7-point scale: 1 = "never", 2 = "less than once a week", 3 = "once or twice a week", 4 = "several times a week", 5 = "once or twice a day", 6 = "several times a day" and 7 = "several times per hour." Ratings pertain to the period of time over the previous 2 weeks preceding administration of the CMAI. CMAI total scores range from 29 to 203. |
Secondary
| Measure | Time frame |
|---|---|
| Change in Clinical Global Impression-Severity (CGI-S) | Up to Week 8 |
| Change in CMAI-International Psychogeriatric Association (CMAI-IPA) Total Score | Up to Week 8 |
| CMAI sub-score change in Aggressive Behaviors | Up to Week 8 |
| CMAI sub-score change in Physically Non-aggressive Behaviors | Up to Week 8 |
| CMAI sub-score change in Verbally Agitated Behaviors | Up to Week 8 |
| Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) Total Score | Up to Week 8 |
| Change in NPI-NH Agitation/Aggression Domain Score | Up to Week 8 |
| Change in NPI-NH Occupational Disruptiveness for Agitation/aggression Domain | Up to Week 8 |
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Up to Day 28 After Last Dose |
| Number of Participants with Serious Adverse Events (SAEs) | Up to Day 28 After Last Dose |
| Number of Participants with Adverse Events (AEs) | Up to Day 28 After Last Dose |
| Number of Participants with Clinically Significant Laboratory Abnormalities | Up to 28 Days After Last Dose |
| Change in Suicidal Ideation Assessed by Sheehan-Suicidality Tracking Scale (S-STS) | Up to Day 28 After Last Dose |
| Change in Behaviour Assessed by Sheehan-Suicidality Tracking Scale (S-STS) | Up to Day 28 After Last Dose |
| Abuse Potential Assessed by the Cannabis Withdrawal Scale (CWS) | Up to Day 21 After Last Dose |
| Withdrawal Symptoms Assessed by the Cannabis Withdrawal Scale (CWS) | Up to Day 21 After Last Dose |
| Plasma Concentrations of BMS-986368 | Up to Week 14 |
Countries
Argentina, Australia, China, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed