Language: BG BG
← Back to results
Recruiting Phase 3 NCT06976216

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

Phase 3 – large-scale trial before approval
Conditions: Alzheimer's Disease

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Who can participate
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.
Locations 17
Argentina (1)
Local Institution - 0001
Buenos Aires , Buenos Aires F.D.
NOT_YET_RECRUITING
Australia (1)
Southern Neurology
Kogarah , New South Wales
Colin Mahoney, Site 0279
Brazil (1)
Local Institution - 0168
Brasília , Federal District
NOT_YET_RECRUITING
Canada (1)
OCT Research ULC
Kelowna , British Columbia
Pieter Strauss, Site 0233
Chile (1)
Local Institution - 0230
Antofagasta , AN
NOT_YET_RECRUITING
Croatia (1)
Local Institution - 0215
Zagreb , City of Zagreb
NOT_YET_RECRUITING
Czech Republic (1)
Neuro Health Centrum
Brno , Brno-město
Katerina Sheardova, Site 0227
Germany (1)
Local Institution - 0219
Münster , North Rhine-Westphalia
NOT_YET_RECRUITING
Greece (1)
University General Hospital of Alexandroupoli
Alexandroupoli , Anatolikí Makedonía Kai Thráki
KONSTANTINOS VADIKOLIAS, Site 0281
India (1)
Local Institution - 0288
Bengaluru , Karnataka
NOT_YET_RECRUITING
Italy (1)
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan , Lombardy
Andrea Arighi, Site 0249
Poland (1)
Local Institution - 0262
Poznan , Greater Poland Voivodeship
NOT_YET_RECRUITING
Puerto Rico (1)
Local Institution - 0181
San Juan
NOT_YET_RECRUITING
Romania (1)
Local Institution - 0273
Bucharest , Bucharest
NOT_YET_RECRUITING
South Korea (1)
Chonnam National University Hospital
Gwangju , Kwangju-Kwangyǒkshi
Byeong Chae Kim, Site 0209
Spain (1)
Hospital Victoria Eugenia
Seville , Andalusia
Felix Viñuela Fernandez, Site 0255
United States (1)
Healthy Brain Clinic
Long Beach , California
Dung Trinh, Site 0173
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
60 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
14.07.2025
Completion date
23.02.2029
Registry ID
NCT06976216
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.