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NCT06947941

NCT06947941
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must be between 55 and 90 years old at the time of your first screening visit.
  • You must have been diagnosed with Alzheimer's disease based on the most recent 2024 Alzheimer's Association guidelines.
  • You must have had a brain scan (MRI or CT) within the past 5 years, taken after your dementia symptoms began, to rule out other brain conditions such as stroke or tumors.
  • You must have been experiencing psychotic symptoms (such as hallucinations or delusions) for at least 2 months before your screening visit — you may or may not also have symptoms of agitation.

Who may not be able to join:

  • You may not be eligible if your psychotic symptoms are caused by a condition other than Alzheimer's disease, such as schizophrenia, schizoaffective disorder, delusional disorder, or a mood disorder with psychotic features.
  • You may not be eligible if you have had a major depressive episode with psychotic features in the past 12 months, or if you have a history of bipolar disorder, schizophrenia, or schizoaffective disorder.
  • You may not be eligible if certain safety concerns are identified, including abnormal results on specific laboratory tests (confirm with trial site for details).
  • There are additional eligibility requirements not listed here that the trial team will review with you (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.

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.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Bristol-Myers Squibb
Registry
clinicaltrials_gov
Start date
25 March 2026
Est. completion
21 February 2028

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇯🇵 Japan 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov