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Monoclonal Antibodies

JNJ-64042056 for Alzheimer's Disease (Reτain Trial)

Phase 2
Recruiting
Research Sponsored by Janssen Pharmaceutica N.V., Belgium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) > 1.1 on a screening tau PET scan, reviewed centrally by a qualified reader
Be older than 18 years old
Must not have
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
History consistent with or known autosomal dominant AD (mutation identified in the family and/or participant)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 102, 154 and 206
Awards & highlights

Summary

This trial aims to see if a new drug, JNJ-64042056, can slow down cognitive decline in people with early Alzheimer's disease, compared to a placebo.

Who is the study for?
This trial is for individuals who are at risk of developing Alzheimer's disease but do not yet show symptoms (preclinical). Participants should be in good general health and have certain biomarkers indicating a high likelihood of progressing to Alzheimer's.
What is being tested?
The study tests the effects of JNJ-64042056 on preventing cognitive decline compared to a placebo. Cognitive function will be measured using the PACC-5 scale, which assesses memory and thinking skills.
What are the potential side effects?
Potential side effects are not specified here, but common ones for similar drugs include headache, nausea, dizziness, or reactions at the injection site. The exact side effects would depend on how JNJ-64042056 works in the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain scan shows high tau protein levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a form of dementia, such as Alzheimer's, FTD, or Lewy Body.
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My family or I have a confirmed genetic mutation for Alzheimer's disease.
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I have been diagnosed with Mild Cognitive Impairment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 102, 154 and 206
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 102, 154 and 206 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Preclinical Alzheimer's Disease Cognitive Composite 5 (PACC-5) Total Scores up to Week 206
Secondary outcome measures
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living -Prevention Instrument (ADCS-ADL-PI)
Change From Baseline in Brain Tau Burden as Measured by Tau PET in Other ROI
Change From Baseline in Brain tau Burden as Measured by tau PET
+18 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: JNJ-64042056Experimental Treatment1 Intervention
Participants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 until Week 180.
Group II: Arm B: PlaceboPlacebo Group1 Intervention
Participants will receive IM injection of placebo from Week 0 until Week 180.

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Who is running the clinical trial?

Janssen Pharmaceutica N.V., BelgiumLead Sponsor
79 Previous Clinical Trials
29,991 Total Patients Enrolled
Janssen Pharmaceutica N.V., Belgium Clinical trialStudy DirectorJanssen Pharmaceutica N.V., Belgium
~332 spots leftby Jul 2031
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