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KarXT for Alzheimer's-Related Psychosis (ADEPT-3 Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by Karuna Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initial dose through 14 days after the final dose (up to 54 weeks)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will assess the long-term safety and tolerability of KarXT for people with Alzheimer's-related psychosis.

Who is the study for?
This trial is for people aged 55 to 90 with psychosis linked to Alzheimer's who finished the KAR-031 study. They must understand the study, give consent (or have a representative do so), and have a caregiver. Those with severe medical issues or recent significant test abnormalities can't join.
What is being tested?
The trial tests KarXT's long-term safety and tolerability in treating psychosis in Alzheimer's patients over a year. It’s an extension of a previous study where participants continue receiving KarXT after completing the initial phase.
What are the potential side effects?
While specific side effects are not listed here, generally, this type of medication could cause dizziness, nausea, sleep disturbances, or changes in blood pressure or heart rate among other potential side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initial dose through 14 days after the final dose (up to 54 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initial dose through 14 days after the final dose (up to 54 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-emergent adverse events (TEAEs)
Secondary study objectives
Incidence of TEAEs leading to withdrawal
Incidence of serious TEAEs

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: KarXTExperimental Treatment1 Intervention
Xanomeline and Trospium Chloride Capsules

Find a Location

Who is running the clinical trial?

Karuna TherapeuticsLead Sponsor
16 Previous Clinical Trials
3,734 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,388,301 Total Patients Enrolled
Paul Yeung, MD, MPHStudy DirectorKaruna Therapeutics, Inc.
2 Previous Clinical Trials
780 Total Patients Enrolled
Ronald Marcus, MDStudy DirectorKaruna Therapeutics, Inc.
4 Previous Clinical Trials
1,111 Total Patients Enrolled

Media Library

KarXT (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05980949 — Phase 3
Alzheimer's Disease Research Study Groups: KarXT
Alzheimer's Disease Clinical Trial 2023: KarXT Highlights & Side Effects. Trial Name: NCT05980949 — Phase 3
KarXT (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05980949 — Phase 3
~145 spots leftby Apr 2026
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