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Tests treatment safety and results 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)
ClinicalTrials.gov ID: NCT05980949
What this study is testing
What is KarXT?
KarXT is an investigational medicine, given as an once-daily, being studied as a potential treatment for psychosis associated with alzheimer's disease.
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
- 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.
- 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. This Inclusion criterion is not applicable for Protocol Amendment...
- Can understand the nature of the study and protocol requirements and provide a signed informed consent (IC) form before any study assessments are...
- 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's taking place
- Homewood, Alabama, United States
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Anaheim, California, United States
- Chino, California, United States
- Costa Mesa, California, United States
- Encino, California, United States
- Irvine, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Pasadena, California, United States
- Rancho Cucamonga, California, United States
- Sherman Oaks, California, United States
- Walnut Creek, California, United States
- Colorado Springs, Colorado, United States
+ 275 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Homewood, Alabama, United States; Chandler, Arizona, United States; Gilbert, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Anaheim, California, United States and 289 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.