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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 2

Conditions: Preclinical Alzheimer's Disease

Treatments: Drug: JNJ-64042056; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06544616

64042056ALZ2001 (Other Identifier)

2023-505096-68-00 (Registry Identifier)

Details and patient eligibility

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.

Enrollment: 498 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) greater than (>) 1.1 on a screening tau PET scan, reviewed centrally by a qualified reader
• 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)
• 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 in the opinion of the investigator it does not require treatment
• History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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498 participants in 2 patient groups, including a placebo group

Arm A: JNJ-64042056

Experimental group

Description:

Participants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 until Week 180.

Treatment:

Drug: JNJ-64042056

Arm B: Placebo

Placebo Comparator group

Description:

Participants will receive IM injection of placebo from Week 0 until Week 180.

Treatment:

Drug: Placebo

Sponsor of this trial

Lead Sponsor

Janssen (J&J Innovative Medicine)