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Активно (без набиране) Фаза 2 NCT06544616

A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Preclinical Alzheimer's Disease

Спонсор: Janssen Pharmaceutica N.V., Belgium

Налично на: БГ
Обобщение
The purpose of this study is to assess the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.
Кой може да участва
Inclusion Criteria: * Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) greater than (\>) 1.1 (or equivalent based on emerging data) on a screening tau PET scan, reviewed centrally by a qualified reader to enrich for probability of disease progression during the study * Clinical Dementia Rating (CDR) global score of 0 at screening and baseline * Mini Mental State Examination (MMSE) greater than or equal to (\>=) 27 (with educational adjustment) at screening * Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening * A participant must be of non-childbearing potential Exclusion Criteria: * History consistent with or known autosomal dominant AD (mutation identified in the family and/or participant) * Fulfills diagnostic criteria for Alzheimer's Dementia or non-Alzheimer's Dementia, including, but not limited to Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), Vascular Dementia (VAD), alcoholic dementia, Parkinson's dementia, Korsakov, Creutzfeldt-Jakob or other prion diseases, Posterior Cortical Atrophy * Diagnosis of Mild Cognitive Impairment (MCI) * Vitamin B12 or folate levels below the central laboratory lower limit of normal, unless the investigator determines that supplementation is not required after randomization * History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult
Места на провеждане 9
Австралия (1)
Neuro Trials Victoria
Carlton
Белгия (1)
Az Groeninge
Kortrijk
Франция (1)
Hopital Roger Salengro - CHU Lille
Lille
Германия (1)
Universitaetsklinikum der RWTH Aachen
Aachen
Япония (1)
Enomoto Internal Medicine Clinic
Chofu-shi
Испания (1)
Barcelona Beta Brain Research Center
Barcelona
Швеция (1)
Skanes universitetssjukhus
Malmo
Великобритания (1)
Royal United Hospital
Bath
САЩ (1)
Xenoscience Inc.
Phoenix , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
55 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
22.07.2024
Крайна дата
16.07.2032
Регистрационен номер
NCT06544616
Източник
anzctr
Запитване за медицински туризъм

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