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

Active Not RecruitingPhase 2

Sponsor: Janssen Pharmaceutica N.V., Belgium

Conditions: Alzheimer Disease

Interventions: JNJ-64042056, Placebo

Countries: United States, Australia, Belgium, France, Germany, Japan, Spain, Sweden

The purpose of this study is to assess whether JNJ-64042056 affects the spread and build up of tau (a protein in brain) when compared with placebo, using brain scan (tau PET) to determine results from specific areas of the brain.

Eligibility overview

Sex: ALL

Age: 55 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (90)

Phoenix, Arizona, United States
Irvine, California, United States
Murrieta, California, United States
Riverside, California, United States
San Diego, California, United States
New Haven, Connecticut, United States
Atlantis, Florida, United States
Boca Raton, Florida, United States
Clermont, Florida, United States
Jacksonville, Florida, United States
Lady Lake, Florida, United States
Maitland, Florida, United States
Merritt Island, Florida, United States
Orlando, Florida, United States
Stuart, Florida, United States
Tampa, Florida, United States
The Villages, Florida, United States
Wellington, Florida, United States
West Palm Beach, Florida, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Farmington Hills, Michigan, United States
Hattiesburg, Mississippi, United States
Springfield, New Jersey, United States
Albany, New York, United States
East Syracuse, New York, United States
New York, New York, United States
Matthews, North Carolina, United States
Centerville, Ohio, United States
Plymouth Meeting, Pennsylvania, United States
+ 60 more on CT.gov