Phase 3 Alzheimer's Disease Trial, Recruiting NCT06126224 Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company Condition: Alzheimer's Disease
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Phase 3 Alzheimer's Disease Trial, Recruiting

NCT06126224
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:

  • You are between 55 and 90 years old (inclusive)
  • You are able to understand what the trial involves and can give your consent to participate
  • You have been diagnosed with possible or probable Alzheimer's disease
  • You have had a brain scan (MRI or CT) within the past 5 years to rule out other causes of your dementia, or you are willing to have one done during the screening process
  • You have been living in the same home or assisted-living facility for at least 6 weeks before joining
  • You have someone in your life (such as a family member or carer) who has contact with you for around 10 or more hours per week
  • You have been experiencing psychotic symptoms (such as hallucinations or delusions) for at least 2 months before screening
  • Your symptoms are rated at a certain level of severity on medical assessment scales at both screening and baseline (confirm with trial site)
  • Your Alzheimer's-related hallucinations and delusions meet a specific severity threshold on a standard assessment tool (confirm with trial site)
  • Your memory and thinking abilities fall within a certain range on a standard cognitive test (confirm with trial site)

Who may not be able to join:

  • Your psychotic symptoms appear to be caused by something other than your Alzheimer's disease
  • You have had a major episode of depression with psychotic features in the past 12 months
  • You have a history of bipolar disorder, schizophrenia, or schizoaffective disorder
  • You have serious or severe health conditions affecting organs such as the lungs, liver, kidneys, heart, or other significant medical issues that the trial doctor feels could affect your safety or the study results
  • You have a history of, or are considered at high risk for, difficulty passing urine, stomach retention problems, or a specific type of eye pressure condition called narrow-angle glaucoma
  • You have previously been treated with the study drug KarXT
  • You have had an allergic reaction to KarXT or a medication called trospium chloride
  • You have previously had significant side effects from a medication called trospium
  • You have taken part in another clinical trial involving an experimental drug within the past 3 months, or have been in more than 2 clinical trials in the past 12 months
  • There may be additional criteria 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.

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 21 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
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Registry
ClinicalTrials.gov
Start date
28 August 2023
Est. completion
9 December 2026

Where this trial is recruiting

🇧🇪 Belgium 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇬🇷 Greece 🇭🇺 Hungary 🇲🇽 Mexico 🇵🇪 Peru 🇵🇱 Poland 🇰🇷 South Korea 🇨🇭 Switzerland Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Change from Baseline to End of Treatment in the 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: 21 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