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Taking peoplePhase 3

Long-Term Safety Study of KarXT for Psychosis in Alzheimer's Disease

Tests KarXT, a long-term safety study in people with Alzheimer's-related psychosis.

Key facts

Who runs it
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Where
Boeblingen, Erbach, Frankfurt Am Main, and Homburg, GermanySee the 4 sitesAlso in 30 other countries, 379 sites
Registry title
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
Status
Recruiting
Phase
Phase 3
People taking part
1,000 people, planned
Started
11 Jul 2023
Expected to end
7 Sept 2027
Type of study
Interventional
Treatments tested
  • KarXT
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with psychosis linked to Alzheimer's disease who finished one of the earlier KarXT studies (CN012-0026, CN012-0027 or CN012-0056). It tests long-term safety of KarXT for 52 weeks.

Age
55 to 90 years
Sex
All sexes can join.
Disease stage
Psychosis associated with Alzheimer's disease.
Earlier treatment
Must have completed study KAR-031 (CN012-0026), KAR-032 (CN012-0027) or CN012-0056. This does not apply to Protocol Amendment 07 or later versions.

Main reasons for not taking part

  • Serious medical conditions that the investigator thinks could risk safety or the study results
  • Test or exam findings at the end of the earlier study that the investigator thinks risk safety
  • Taking part in, or planning to take part in, another investigational drug or device study

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Must have completed study KAR-031 (CN012-0026), KAR-032(CN012-0027), or CN012-0056. This Inclusion criterion is not applicable for Protocol Amendment 07 or later versions
  • Can understand the nature of the study and protocol requirements and provide a signed informed consent (IC) form before any study assessments are performed. If the subject is deemed not competent to provide IC, both the following requirements for consent must be met:; The subject's legally acceptable representative (LAR) must provide IC; The subject must provide informed assent
  • Must have stable living environment. At entry into this study, or any time during the study, if a subject needs to relocate from home, a residential assisted-living facility, or other stable location to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study

Who cannot take part

  • Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of KAR-033
  • Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results
  • Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study KAR-031 (Visit 19), Study KAR-032 (Visit 12), Study CN012-0056 (Visit 12) that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject
  • Other protocol-defined Inclusion/Exclusion criteria apply

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 55 and 90 years old?
  • Has a doctor told you that you have Alzheimer's disease?
  • Do you have hallucinations or delusions caused by Alzheimer's disease?

Where in Germany

Also in 30 other countries, 379 sites

  • Studienzentrum Dr. Bischof GmbHBoeblingen, GermanyNo longer taking part
  • Neuro Centrum Science GmbHErbach, GermanyNo longer taking part
  • Goethe University FrankfurtFrankfurt Am Main, GermanyNo longer taking part
  • Universitaet Des SaarlandesHomburg, GermanyNo longer taking part

About the trial

What the trial wants to find out

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.

The group in the trial

  • KarXTTreatment being tested

    Xanomeline and Trospium Chloride Capsules

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
Plain-language title
Long-Term Safety Study of KarXT for Psychosis in Alzheimer's DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05980949, who can take part
Record updated
12 November 2026