Phase 3 Alzheimer's Disease Trial, Recruiting NCT06976216 Sponsor: Bristol-Myers Squibb Condition: Alzheimer's Disease
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Phase 3 Alzheimer's Disease Trial, Recruiting

NCT06976216
Recruiting Phase 3 🇦🇺 Australian site

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 a confirmed diagnosis of Alzheimer's disease at the mild (stage 4) or moderate (stage 5) dementia stage, diagnosed according to the most recent official criteria from the National Institute on Aging and Alzheimer's Association (NIA-AA).
  • People whose score on a standard memory and thinking test (called the MMSE) falls between 12 and 22 at the time of initial screening.
  • People who have a designated caregiver who spends around 10 or more hours per week with them, is willing to attend all study visits, and agrees to help monitor the participant's condition and medication.
  • People who are taking Alzheimer's medications (AChEIs and/or memantine) must have been on a stable dose for at least 12 weeks before screening, with an agreement to keep that dose unchanged throughout the study.

Who may not be able to join:

  • People who have significant or serious medical conditions that could affect their safety or the reliability of the study results — including any level of liver problems, difficulty passing urine, active gallbladder disease, moderate-to-severe kidney problems, or unstable high blood pressure or abnormally fast heart rate.
  • People who have a primary psychiatric diagnosis such as major depression, schizoaffective disorder, or bipolar disorder, or who have severe psychiatric symptoms that could affect cognitive testing or study completion.
  • People who have a history of schizophrenia or long-term psychosis, who have previously been treated with a drug called KarXT, or who have received disease-modifying anti-amyloid treatments for Alzheimer's disease within the past 6 months before screening.
  • People whose brain MRI scan at screening shows significant findings unrelated to Alzheimer's disease, or findings that could affect safety or interfere with the study.
  • Additional criteria not listed here 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 23 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

Australian sites

Southern Neurology, Kogarah, New South Wales
+61 2 8566 1500
KARA Institute for Neurological Diseases, Macquarie Park, New South Wales
61 2 8960 7788
NeuroCentrix, Carlton, Victoria
+61 3 9546 0009
Neurodegenerative Disorders Research, Perth, Western Australia
+61 8 6317 9472
St Vincent's Hospital Sydney Limited, Darlinghurst,
61 2 8382 4983

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
14 July 2025
Est. completion
11 September 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇭🇷 Croatia 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇳 India 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇱 Poland Puerto Rico 🇷🇴 Romania 🇰🇷 South Korea 🇪🇸 Spain 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11); Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+)

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: 23 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