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Активно (без набиране) Фаза 2 NCT06268886

Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Alzheimer Disease, Early Onset

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.
Кой може да участва
Inclusion Criteria * Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria. * Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline. * Evidence of AD pathology. * Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II). * Mini Mental Status Examination (MMSE) score ≥ 20 to 28 (inclusive). Exclusion Criteria * Any evidence of a condition that may affect cognition other than AD. * Contraindications to PET imaging. * Inability to tolerate or contraindication to magnetic resonance imaging. * Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments. * Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening. * Other protocol-defined Inclusion/Exclusion criteria apply.
Места на провеждане 10
Австралия (1)
Local Institution - 0111
East Gosford , New South Wales
Белгия (1)
Local Institution - 0122
Anderlecht , Brussels Capital
Канада (1)
Local Institution - 0112
Ottawa , Ontario
Япония (1)
Local Institution - 0181
Nagoya , Aichi-ken
Сингапур (1)
Local Institution - 0091
Singapore
Южна Корея (1)
Local Institution - 0117
Songpa-gu , Seoul
Испания (1)
Local Institution - 0158
Barcelona , B
Швеция (1)
Local Institution - 0167
Malmo , M
Великобритания (1)
Local Institution - 0121
Enfield , LND
САЩ (1)
Local Institution - 0068
Chandler , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
50 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
20.03.2024
Крайна дата
18.03.2027
Регистрационен номер
NCT06268886
Източник
anzctr
Запитване за медицински туризъм

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