Phase 3 Alzheimer's Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with Alzheimer's disease according to 2024 guidelines, confirmed through brain imaging (a special PET scan) or blood/spinal fluid tests that show Alzheimer's-related changes in the body.
- You scored between 5 and 22 on a standard memory and thinking test called the MMSE, measured at your first screening visit.
- You have one identified caregiver who spends roughly 10 or more hours per week with you, and who is willing to attend all study visits, help you follow the study rules, and take part in study assessments themselves.
- You have a history of agitation (restlessness or distress) that meets specific international guidelines for agitation in people with memory disorders, and this agitation began at least two weeks before your first screening visit.
- Your agitation and aggression scores on specific rating scales used by researchers (called NPI/NPI-NH and CGI-S) meet a minimum threshold at both the screening and baseline visits.
- You show a certain level of aggressive behaviors (physical or verbal) happening regularly — for example, at least one aggressive behavior several times a week, or multiple aggressive behaviors at least once or twice a week (confirm with trial site for exact details).
Who may not be able to join:
- Your agitation appears to be caused by something other than Alzheimer's disease.
- You have a history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- You have a history of, or are considered at high risk for, difficulty urinating, stomach/digestive retention issues, or a specific type of eye condition called narrow-angle glaucoma (confirm with trial site).
- You are considered by the study doctor to be at risk of suicidal thoughts or behaviour during the study.
- You have recently taken certain medications, including MAO inhibitors, some anti-seizure drugs, mood stabilizers like lithium, or older-style antidepressants — though some antidepressants (SSRIs or SNRIs) may be allowed if you have been on a stable dose for at least 8 weeks before screening.
- You are taking certain sleep aids (mirtazapine or trazodone) unless you started them at least 8 weeks before your first screening visit.
- There may be additional eligibility requirements not listed here (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb
Phone: 855-907-3286
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score at Week 14
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.