KarXT for Alzheimer's Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Clinical Trial Site, Lafayette, CA
Alzheimer's Disease+4 More
KarXT - Drug
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

2 of 3
This is further along than 85% of similar trials

Other trials for Alzheimer's Disease

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

3 of 3
This is further along than 85% of similar trials

Other trials for Alzheimer's Disease

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: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 38
Closest Location: Clinical Trial Site · Lafayette, CA
Photo of california 1Photo of california 2Photo of california 3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.