Phase 3 Alzheimer's Disease Trial, Recruiting NCT07011732 Sponsor: Bristol-Myers Squibb Condition: Alzheimer's Disease
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Phase 3 Alzheimer's Disease Trial, Recruiting

NCT07011732
Recruiting Phase 3

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:

  • People who have been diagnosed with Alzheimer's disease according to 2024 Alzheimer's Association standards, confirmed through brain imaging (amyloid PET scan) or specific protein measurements in blood or spinal fluid using an approved diagnostic test.
  • People who score 24 or below on a standard memory and thinking test called the Mini-Mental State Examination (MMSE) at the start of the trial.
  • People who have an identified caregiver who spends around 8 hours per week with them, and who is willing to attend all trial visits, help with medication, and take part in study assessments.
  • People who have a history of agitation (as defined by an international medical organisation called the IPA) that began at least two weeks before the trial screening visit.
  • People whose agitation and aggression scores meet a minimum threshold on two specific rating scales (NPI/NPI-NH and CMAI-IPA) at both the screening and baseline visits.

Who may not be able to join:

  • People whose agitation appears to be caused by something other than their Alzheimer's disease.
  • People with a history of bipolar disorder, schizophrenia, or schizoaffective disorder.
  • People who have, or are considered at high risk of having, problems with urinary retention, stomach retention, or a specific type of eye condition called narrow-angle glaucoma (confirm with trial site).
  • People considered by the investigating doctor to be at risk of suicidal behaviour during the study.
  • People who have recently taken certain medications, including MAO inhibitors, some anti-seizure medications, mood stabilisers, or tricyclic antidepressants — though some antidepressants (such as SSRIs or SNRIs) taken at a stable dose for at least 8 weeks before screening may be permitted, as may certain sleep or agitation medications started at least 8 weeks prior (confirm with trial site).
  • Additional criteria set out in the study protocol may also apply (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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
10 July 2025
Est. completion
24 November 2028

Where this trial is recruiting

🇦🇷 Argentina 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇭🇷 Croatia 🇬🇷 Greece 🇮🇳 India 🇯🇵 Japan 🇲🇽 Mexico 🇵🇹 Portugal 🇷🇴 Romania 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

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?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov