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A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study, to Assess Efficacy, Safety and Immunogenicity of JNJ-64042056, a Phosphorylated Tau Targeted Active Immunotherapy, in Participants with Preclinical Alzheimer's Disease (ReTain)

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

Fukushima Takashi

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Medical Information Center

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

+81-120-183-275

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Not Recruiting

Oct. 16, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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

- 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

Both

Alzheimer Disease

Experimental: Arm A: JNJ-64042056
Participants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 up to a maximum of Week 76.

Drug: JNJ-64042056
JNJ-64042056 will be administered intramuscularly.

Placebo Comparator: Arm B: Placebo
Participants will receive IM injection of placebo from Week 0 up to a maximum of Week 76.

Drug: Placebo
Placebo will be administered intramuscularly.

1. Change From Baseline in Brain Tau Burden as Measured by Tau PET in Specified Regions of Interest (ROI)
Change from baseline in brain tau burden, as measured by tau PET (including but not limited to Braak I-VI ROIs, tau naive composite ROI, Connection Rank ROI, and New Tau Composite ROI Volume) will be reported.
[Time Frame: Baseline up to Week 102]

Refer to Appendix

Mar. 21, 2024

Yes

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

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