Alzheimer Disease study: KarXT vs KarX-EC
Official title A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
ClinicalTrials.gov ID: NCT06937229
What this study is testing
What is KarXT?
KarXT is an investigational medicine, taken by mouth, being studied as a potential treatment for alzheimer disease.
Also referred to as Xanomeline and Trospium Chloride capsule, BMS-986510.
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 study aims to find out how well the combined KarXT and KarX-EC treatment works over time and how safe it is for people with Alzheimer’s‑related agitation.
- Who it's for
- Adults with Alzheimer’s disease who have agitation and who have already finished the earlier CN012‑0023 or CN012‑0024 studies.
- What's involved
- Participants will take an immediate‑release KarXT capsule and an enteric‑coated KarX‑EC capsule and will have regular clinic visits for safety checks and assessments.
- Phase 3: a large, late-stage study
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
- Participants must have completed study CN012-0023 or CN012-0024 per protocol.
- Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).
You likely can't join if
- Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia)...
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Miami, Florida, United States
- Port Orange, Florida, United States
- Tampa, Florida, United States
- Virginia Gardens, Florida, United States
- Newton, Massachusetts, United States
- Las Vegas, Nevada, United States
- Morehead City, North Carolina, United States
- Carrollton, Texas, United States
- Cypress, Texas, United States
- El Paso, Texas, United States
- Córdoba, Argentina
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, Brazil
- Sofia, Bulgaria
- Whitby, Ontario, Canada
- Nanjing, Jiangsu, China
- Tianjin, Tianjin Municipality, China
- Olomouc, Olomouc Region, Czechia
- Brno, South Moravian, Czechia
+ 40 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 Scottsdale, Arizona, United States; Miami, Florida, United States; Port Orange, Florida, United States; Tampa, Florida, United States; Virginia Gardens, Florida, United States; Newton, Massachusetts, United States and 54 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.