Psychosis Associated With Alzheimer's Disease study: KarXT
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)
ClinicalTrials.gov ID: NCT05980949
What this study is testing
What is KarXT?
KarXT is an investigational oral medicine being studied as a potential treatment for psychosis associated with Alzheimer's disease. It is designed to activate central muscarinic receptors while blocking peripheral muscarinic effects, aiming to improve brain signaling linked to psychosis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal is to see if the drug is safe and well-tolerated over a long period of time.
- Who it's for
- This study is for people who have already finished a previous short-term study of this drug.
- What's involved
- Participants will continue taking the drug and visit the clinic for regular check-ups and safety tests.
- Time commitment
- The study lasts for 52 weeks and requires regular visits to the clinic.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 90
You may be able to join if
- Must have completed study KAR-031 (CN012-0026), KAR-032(CN012-0027), or CN012-0056.
- 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...
You likely can't join if
- Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or...
- Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit...
- people participating in another investigational drug or device study or planning on participating in another clinical study during the duration of...
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Anaheim, California, United States
- Los Angeles, California, United States
- Pasadena, California, United States
- Walnut Creek, California, United States
- Farmington, Connecticut, United States
- Bonita Springs, Florida, United States
- Clermont, Florida, United States
- Cutler Bay, Florida, United States
- Daytona Beach, Florida, United States
- Doral, Florida, United States
- Hialeah, Florida, United States
- Homestead, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Miami Gardens, Florida, United States
- Miami Lakes, Florida, United States
- Miami Springs, Florida, United States
- Orlando, Florida, United States
- Ormond Beach, Florida, United States
- Tampa, Florida, United States
+ 74 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anaheim, California, United States; Los Angeles, California, United States; Pasadena, California, United States; Walnut Creek, California, United States; Farmington, Connecticut, United States; Bonita Springs, Florida, United States and 88 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.