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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Specified dose on specified days
Specified dose on specified days
Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline
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.
Time frame: Up to Week 8
Change in Clinical Global Impression-Severity (CGI-S)
Time frame: Up to Week 8
Change in CMAI-International Psychogeriatric Association (CMAI-IPA) Total Score
Time frame: Up to Week 8
CMAI sub-score change in Aggressive Behaviors
Time frame: Up to Week 8
CMAI sub-score change in Physically Non-aggressive Behaviors
Time frame: Up to Week 8
CMAI sub-score change in Verbally Agitated Behaviors
Time frame: Up to Week 8
Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) Total Score
Time frame: Up to Week 8
Change in NPI-NH Agitation/Aggression Domain Score
Time frame: Up to Week 8
Change in NPI-NH Occupational Disruptiveness for Agitation/aggression Domain
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain the NCT# and Site #.
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution - 0046
Homewood, Alabama, United States
NOT_YET_RECRUITINGUniversity of Alabama - Huntsville Regional Medical Campus
Huntsville, Alabama, United States
RECRUITINGNoesisPharma
Phoenix, Arizona, United States
RECRUITINGLocal Institution - 0040
Scottsdale, Arizona, United States
NOT_YET_RECRUITINGLocal Institution - 0017
Anaheim, California, United States
NOT_YET_RECRUITINGInland Psychiatric Medical Group, Inc
Chino, California, United States
RECRUITINGKaizen Brain Center
La Jolla, California, United States
RECRUITINGUniversity of California San Diego - La Jolla
La Jolla, California, United States
RECRUITINGShreenath Clinical Service - Lakewood
Lakewood, California, United States
RECRUITINGAccellacare - Sherman Oaks
Sherman Oaks, California, United States
RECRUITING...and 42 more locations
Time frame: Up to Week 8
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 28 After Last Dose
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 28 After Last Dose
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 28 After Last Dose
Number of Participants with Clinically Significant Laboratory Abnormalities
Time frame: Up to 28 Days After Last Dose
Change in Suicidal Ideation Assessed by Sheehan-Suicidality Tracking Scale (S-STS)
Time frame: Up to Day 28 After Last Dose
Change in Behaviour Assessed by Sheehan-Suicidality Tracking Scale (S-STS)
Time frame: Up to Day 28 After Last Dose
Abuse Potential Assessed by the Cannabis Withdrawal Scale (CWS)
Time frame: Up to Day 21 After Last Dose
Withdrawal Symptoms Assessed by the Cannabis Withdrawal Scale (CWS)
Time frame: Up to Day 21 After Last Dose
Plasma Concentrations of BMS-986368
Time frame: Up to Week 14