JNJ-63733657 for Dementia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Dementia+2 More
JNJ-63733657 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether a new drug can slow down Alzheimer's disease.

Eligible Conditions
  • Dementia
  • Alzheimer Disease
  • Cognitive Decline

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 21 Secondary · Reporting Duration: Baseline up to 4.5 years (End of treatment)

Week 4
Serum Concentrations of JNJ-63733657
Week 52
CSF Concentrations of JNJ-63733657
Week 245
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) score
Year 5
Changes From Baseline in Brain Magnetic Resonance Imaging (MRI) Safety Findings
Week 245
Number of Participants with Clinical Laboratory Abnormalities
Year 5
Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive subscale 13-item version (ADAS-Cog 13) Total Score
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL MCI)
Change From Baseline in Brain tau Burden as Measured by tau PET
Change From Baseline in Cerebrospinal Fluid (CSF) concentrations of Total, Free, and Bound p217+tau Fragments
Change From Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB)
Change From Baseline in RBANS Indices
Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score
Personality inventories
Complementarity Determining Regions
Percentage of Participants Progressing From Clinical Dementia Rating- Global Score (CDR-GS) 0.5 to 1 or Higher
Year 5
Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)
Up to 245 Weeks
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Number of Participants with Electrocardiogram (ECG) Abnormalities
Number of Participants with Physical and Neurological Examination Abnormalities
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Percentage of Participants with Vital Sign Abnormalities
Week 245
Anti-Drug Antibody to JNJ-63733657

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Trial Design

2 Treatment Groups

JNJ-63733657
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

420 Total Participants · 2 Treatment Groups

Primary Treatment: JNJ-63733657 · Has Placebo Group · Phase 2

JNJ-63733657
Drug
Experimental Group · 1 Intervention: JNJ-63733657 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-63733657
2017
Completed Phase 1
~100

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 4.5 years (end of treatment)

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
918 Previous Clinical Trials
6,326,465 Total Patients Enrolled
4 Trials studying Dementia
36,398 Patients Enrolled for Dementia
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
707 Previous Clinical Trials
3,899,443 Total Patients Enrolled
3 Trials studying Dementia
36,341 Patients Enrolled for Dementia

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Illinois100.0%
What site did they apply to?
Great Lakes Clinical Trials100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%