Clinical Trials in the Netherlands / NCT06976216
Recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
NCT06976216 · tracked via the Priya Life Science Netherlands tracker
Condition(s) studied
Alzheimer's Disease
Investigational drug(s) / intervention(s)
KarXT: Specified dose on specified days
KarX-EC: Specified dose on specified days
Placebo: Specified dose on specified days
Study summary
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Eligibility
Inclusion Criteria
* Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.
* Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.
* Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.
* Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.
Exclusion Criteria
* Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of \<50 mL/min), and unstable hypertension or tachycardia.
* Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
* Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
* Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that reflect significant pathology other than AD or could affect safety or interfere with study procedures.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
- Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) — At week 24
- Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+) — At week 24
Trial sites (119)
| Facility | City | Region | Status |
|---|---|---|---|
| Healthy Brain Clinic | Long Beach | California | Recruiting |
| Anderson Clinical Research | Redlands | California | Recruiting |
| Mountain Neurological Research Center | Basalt | Colorado | Recruiting |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | Recruiting |
| JEM Research Institute | Atlantis | Florida | Recruiting |
| VIN-Julie Schwartzbard | Aventura | Florida | Recruiting |
| Merritt Island Medical Research, LLC | Merritt Island | Florida | Recruiting |
| Renstar Medical Research | Ocala | Florida | Recruiting |
| Alzheimer's Research and Treatment Center | Stuart | Florida | Recruiting |
| Charter Research - Lady Lake | The Villages | Florida | Recruiting |
| Local Institution - 0016 | Columbus | Georgia | Withdrawn |
| Center for Advanced Research & Education | Gainesville | Georgia | Recruiting |
| Re:Cognition Health - Chicago | Chicago | Illinois | Recruiting |
| Ascension Alexian Brothers | Elk Grove Village | Illinois | Recruiting |
| Boston Center for Memory | Newton | Massachusetts | Recruiting |
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | Recruiting |
| Advanced Memory Research Institute of New Jersey | Toms River | New Jersey | Recruiting |
| NYU Langone Health | New York | New York | Recruiting |
| Local Institution - 0259 | New York | New York | Active Not Recruiting |
| SUNY Upstate Medical University | Syracuse | New York | Recruiting |
| Local Institution - 0007 | Matthews | North Carolina | Active Not Recruiting |
| Ohio State University | Columbus | Ohio | Recruiting |
| NDx Clinical Research Inc. | Dayton | Ohio | Recruiting |
| Summit Headlands | Portland | Oregon | Recruiting |
| Local Institution - 0004 | Abington | Pennsylvania | Withdrawn |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | Recruiting |
| Neurology Clinic, P.C. | Cordova | Tennessee | Recruiting |
| Gadolin Research | Beaumont | Texas | Recruiting |
| Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM) | Buenos Aires | Buenos Aires F.D. | Recruiting |
| Local Institution - 0271 | Buenos Aires | Argentina | Not Yet Recruiting |
| Fundación Lennox - Instituto Modelo de Neurología | Córdoba | Argentina | Recruiting |
| Sanatorio Morra S.A. | Córdoba | Argentina | Recruiting |
| Instituto Kremer | Córdoba | Argentina | Recruiting |
| Southern Neurology | Kogarah | New South Wales | Recruiting |
| KARA Institute for Neurological Diseases | Macquarie Park | New South Wales | Recruiting |
| NeuroCentrix | Carlton | Victoria | Recruiting |
| Neurodegenerative Disorders Research | Perth | Western Australia | Recruiting |
| St Vincent's Hospital Sydney Limited | Darlinghurst | Australia | Recruiting |
| L2IP - Instituto de Pesquisas Clínicas | Brasília | Federal District | Recruiting |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | Recruiting |
+ 79 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06976216 on ClinicalTrials.gov ↗ ← All trials in the Netherlands