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Active (not recruiting) Phase 2 NCT06544616

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

Phase 2 – studying effectiveness and dosage
Conditions: Preclinical Alzheimer's Disease

Sponsor: Janssen Pharmaceutica N.V., Belgium

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 9
Australia (1)
Neuro Trials Victoria
Carlton
Belgium (1)
Az Groeninge
Kortrijk
France (1)
Hopital Roger Salengro - CHU Lille
Lille
Germany (1)
Universitaetsklinikum der RWTH Aachen
Aachen
Japan (1)
Enomoto Internal Medicine Clinic
Chofu-shi
Spain (1)
Barcelona Beta Brain Research Center
Barcelona
Sweden (1)
Skanes universitetssjukhus
Malmo
United Kingdom (1)
Royal United Hospital
Bath
United States (1)
Xenoscience Inc.
Phoenix , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
55 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
22.07.2024
Completion date
16.07.2032
Registry ID
NCT06544616
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.