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

Sponsored by Janssen Pharmaceutica N.V., Belgium

About this trial

Last updated 2 months ago

Study ID

64042056ALZ2001

Status

Active, not recruiting

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
55 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Location

Status

For more information, view the full study details:

NCT06544616