KarXT for Alzheimer's Disease
Phase-Based Progress Estimates
Effectiveness
Safety
Clinical Trial Site, Lafayette, CA
Alzheimer's Disease+4 More
KarXT - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease dementia. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease dementia treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease dementia treated with KarXT compared to placebo.
Eligible Conditions
- Alzheimer's Disease
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: Week 38
Week 38
Time from randomization to discontinuation for any reason during the 38-week study
Time from randomization to relapse during the 38-week study
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
KarXT
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
380 Total Participants · 2 Treatment Groups
Primary Treatment: KarXT · Has Placebo Group · Phase 3
KarXT
Drug
Experimental Group · 1 Intervention: KarXT · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 38
Closest Location: Clinical Trial Site · Lafayette, CA
2003First Recorded Clinical Trial
0 TrialsResearching Alzheimer's Disease
97 CompletedClinical Trials
Who is running the clinical trial?
Karuna TherapeuticsLead Sponsor
8 Previous Clinical Trials
2,180 Total Patients Enrolled
Rebecca Evans, MDStudy DirectorKaruna Therapeutics
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are living at the same home or residential assisted-living facility for a minimum of six weeks before Screening.
You must be willing to participate in the study.
You are the subject's legally acceptable representative or caregiver/study partner, if local regulations allow, must provide informed consent.
You must be able to understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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