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Набира участници Фаза 3 NCT06976216

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Alzheimer's Disease

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Кой може да участва
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.
Места на провеждане 17
Argentina (1)
Local Institution - 0001
Buenos Aires , Buenos Aires F.D.
NOT_YET_RECRUITING
Австралия (1)
Southern Neurology
Kogarah , New South Wales
Colin Mahoney, Site 0279
Бразилия (1)
Local Institution - 0168
Brasília , Federal District
NOT_YET_RECRUITING
Канада (1)
OCT Research ULC
Kelowna , British Columbia
Pieter Strauss, Site 0233
Chile (1)
Local Institution - 0230
Antofagasta , AN
NOT_YET_RECRUITING
Хърватия (1)
Local Institution - 0215
Zagreb , City of Zagreb
NOT_YET_RECRUITING
Чехия (1)
Neuro Health Centrum
Brno , Brno-město
Katerina Sheardova, Site 0227
Германия (1)
Local Institution - 0219
Münster , North Rhine-Westphalia
NOT_YET_RECRUITING
Гърция (1)
University General Hospital of Alexandroupoli
Alexandroupoli , Anatolikí Makedonía Kai Thráki
KONSTANTINOS VADIKOLIAS, Site 0281
Индия (1)
Local Institution - 0288
Bengaluru , Karnataka
NOT_YET_RECRUITING
Италия (1)
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan , Lombardy
Andrea Arighi, Site 0249
Полша (1)
Local Institution - 0262
Poznan , Greater Poland Voivodeship
NOT_YET_RECRUITING
Puerto Rico (1)
Local Institution - 0181
San Juan
NOT_YET_RECRUITING
Румъния (1)
Local Institution - 0273
Bucharest , Bucharest
NOT_YET_RECRUITING
Южна Корея (1)
Chonnam National University Hospital
Gwangju , Kwangju-Kwangyǒkshi
Byeong Chae Kim, Site 0209
Испания (1)
Hospital Victoria Eugenia
Seville , Andalusia
Felix Viñuela Fernandez, Site 0255
САЩ (1)
Healthy Brain Clinic
Long Beach , California
Dung Trinh, Site 0173
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
60 Years
Максимална възраст
85 Years
Здрави доброволци
Не
Начална дата
14.07.2025
Крайна дата
23.02.2029
Регистрационен номер
NCT06976216
Източник
anzctr
Запитване за медицински туризъм

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