Reτain
Research type
Research Study
Full title
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
IRAS ID
1008651
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
ISRCTN Number
ISRCTN78730935
Research summary
This study will consist of:
- a pre-screening phase (approximately 4 weeks)
- a screening period (up to 13 weeks prior to randomization)
- a double-blind treatment period (approximately 48 months)
- a post-treatment follow-up period (2 weeks)
The participants will be assigned by chance to 1 of 2 treatment groups: JNJ-64042056 or placebo.
JNJ-64042056 or placebo will be administered from Week 0 up to Week 180 through injection into the muscle.
Study assessments will include questionaries, vital signs, electrocardiogram (ECG), blood and urine lab safety (including coagulation, thyroid function, vitamin B12, folic acid), antibody assessments, biomarker assessments, magnetic resonance imaging (MRI), positron emission tomography (PET), physical and neurological examination.
Total study duration for each participant will be approximately 4 years.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0126
Date of REC Opinion
9 May 2024
REC opinion
Further Information Favourable Opinion