Testing KarXT for psychosis associated with Alzheimer's disease
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)
Interventions
KarXT
KarXT 20/2 mg TID (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)
Canadian Sites (5)
Local Institution - 1-12IRCCNP
Calgary, Alberta, Canada
Local Institution - 1603
Hamilton, Ontario, Canada
Local Institution - 1604
Whitby, Ontario, Canada
Local Institution - 1-12IYJCH7
Montreal, Quebec, Canada
Local Institution - 1601
Verdun, Quebec, Canada
Eligibility Criteria
See who this study is looking for9 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Must have completed study KAR-031 (CN012-0026), KAR-032(CN012-0027), or CN012-0056. This Inclusion criterionInclusion criteriaThe things you must have or be for a study to consider you.Read more → is not applicable for ProtocolProtocolThe detailed plan a study must follow.Read more → Amendment 07 or later versions.
- +Can understand the nature of the study and protocol requirements and provide a signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (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 SponsorSponsorThe organisation responsible for the study overall.Read more →/Medical Monitor must approve the subject's participation in the study.
Exclusion
- −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.
- −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.
- −Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of KAR-033.
- −Other protocolProtocolThe detailed plan a study must follow.Read more →-defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: KarXT.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 55 years to 90 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,000 people.
The study is currently expected to finish around September 2027.
The main measurement is taken over: From initial dose through 14 days after the final dose (up to 54 weeks).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence of treatment-emergent adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (TEAEs) — measured over From initial dose through 14 days after the final dose (up to 54 weeks).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05980949 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About KarXTDrug
KarXT 20/2 mg TID (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 55 years to 90 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 55 years to 90 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From initial dose through 14 days after the final dose (up to 54 weeks).
The study as a whole is currently expected to finish around 2027-09-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 13 locations, including: Calgary, Alberta, Canada; Hamilton, Ontario, Canada; Whitby, Ontario, Canada; Montreal, Quebec, Canada; Verdun, Quebec, Canada; Bloomfield Township, Michigan, United States, and 7 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (10)
Local Institution - 1-146Y4PVY
Bloomfield Township, Michigan, United States
Local Institution - 1248
Bloomfield Township, Michigan, United States
Local Institution - 1139
Rochester Hills, Michigan, United States
Local Institution - 1018
Manhasset, New York, United States
Local Institution - 1017
New York, New York, United States
Local Institution - 1034
Stony Brook, New York, United States
Local Institution - 1231
Syracuse, New York, United States
Local Institution - 1240
Syracuse, New York, United States
Five Towns Neurology PC -Woodmere - 923 Broadway
Woodmere, New York, United States
Local Institution - 1254
Kirkland, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.