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Monoclonal Antibodies
JNJ-63733657 for Alzheimer's Disease (Autonomy Trial)
Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Early Alzheimer's disease (AD): Gradual and progressive subjective decline in the participant's cognition over at least the past 6 months, as reported by the participant and informant (study partner) and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 and memory box score >= 0.5 at screening
Early Alzheimer's disease (AD): Gradual and progressive subjective decline in the participant's cognition over at least the past 6 months, as reported by the participant and informant (study partner) and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 and memory box score greater than or equal to (>=) 0.5 at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to 4.5 years (end of treatment)
Awards & highlights
Autonomy Trial Summary
This trial will test whether a new drug can slow down Alzheimer's disease.
Who is the study for?
This trial is for individuals with early Alzheimer's disease who have experienced a gradual cognitive decline over the past 6 months, confirmed by tau PET scans and specific clinical ratings. Participants must be able to read and write, have at least 5 years of education, and commit to not donating sperm during the study. They need a literate study partner likely to complete the study with them.Check my eligibility
What is being tested?
The trial is testing JNJ-63733657 against a placebo in slowing down clinical decline in early Alzheimer's patients. The main measure used will be the Integrated Alzheimer's Disease Rating Scale (iADRS), which assesses both cognition and function.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions typical of medications affecting brain function such as headaches, nausea, dizziness or more serious effects related to mood or cognition changes.
Autonomy Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been experiencing a slow decline in my memory and thinking skills for the past 6 months.
Select...
I have been experiencing a slow decline in my memory and thinking skills for the past 6 months.
Select...
I have early Alzheimer's with worsening memory over the last 6 months.
Autonomy Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and up to 4.5 years (end of treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to 4.5 years (end of treatment)
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 Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score at Week 104
Secondary outcome measures
Anti-Drug Antibody to JNJ-63733657
CSF Concentrations of JNJ-63733657
Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive subscale 13-item version (ADAS-Cog 13) Total Score at Week 104
+18 moreAutonomy Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: JNJ-63733657 Low-doseExperimental Treatment1 Intervention
Participants will receive single dose of JNJ-63733657 low-dose administered by intravenous (IV) infusion every 4 weeks.
Group II: JNJ-63733657 High-doseExperimental Treatment1 Intervention
Participants will receive single dose of JNJ-63733657 high-dose administered by IV infusion every 4 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive single dose of matching placebo to JNJ-63733657 administered by IV infusion every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-63733657
2017
Completed Phase 1
~110
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,785 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,382 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been experiencing a slow decline in my memory and thinking skills for the past 6 months.I have been experiencing a slow decline in my memory and thinking skills for the past 6 months.Your Hachinski Ischemic Scale score is more than 4.I have been diagnosed with MCI or dementia not caused by Alzheimer's.You need to have a positive tau PET scan result.I have early Alzheimer's with worsening memory over the last 6 months.My CNS medication has been stable for 2 months, and I don't use benzodiazepines.My dementia rating is 2 or higher.Your score on the Geriatric Depression Scale (GDS) is higher than 12.I agree not to donate sperm during and up to 4 months after the study.
Research Study Groups:
This trial has the following groups:- Group 1: JNJ-63733657 High-dose
- Group 2: JNJ-63733657 Low-dose
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04619420 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA sanction JNJ-63733657 for use?
"JNJ-63733657's safety was assigned a 2, as there is clinical evidence indicating its security but no studies that confirm the drug's efficacy."
Answered by AI
What is the estimated participant population for this research project?
"To facilitate this clinical trial, 420 individuals must be recruited who meet the set requirements. Those interested can register at Parkwood Institute in London, Ontario or Alzheimers Research and Treatment Center in Wellington, Florida."
Answered by AI
Who is eligible to enroll in this research initiative?
"This clinical trial seeks 420 patients aged between 55 and 80 suffering from dementia. Prospective enrollees must demonstrate symptoms of Early Alzheimer's disease, have a positive tau PET result, be literate with at least 5 years of formal education, possess a study partner that is adequately educated to participate in the research and provide support for the patient during treatment, as well as males agreeing not to donate sperm within 16 weeks following their last dose of medication."
Answered by AI
Is it possible for those over 25 to partake in the experiment?
"The age limits for this medical trial are 55 and 80 respectively, as per the requirements of eligibility."
Answered by AI
How widely is the research being conducted across North America?
"This scientific investigation is accepting participants at 59 sites, with major hubs in London, Wellington and Providence. To minimize transportation demands for volunteers involved in the study, it is suggested to select a trial location nearby."
Answered by AI
Is enrollment in this trial open presently?
"Affirmative. According to information on clinicaltrials.gov, this research is presently recruiting patients that were initially posted on June 1st 2021 and most recently edited in November 9th 2022. 420 individuals are being accepted from 59 diverse sites for the trial."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Other
Pennsylvania
Illinois
What site did they apply to?
Yale University School Of Medicine
Georgetown University Hospital
Other
Great Lakes Clinical Trials
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
What questions have other patients asked about this trial?
Are there any negative effects or consequenses? I do have a pacemaker. Does that disqualify me?
PatientReceived no prior treatments
Why did patients apply to this trial?
Interest in preventing worsening memory. I’ve been in Donapozile. See no positive changes.
PatientReceived 1 prior treatment
Memory loss and Interest in preventing worsening memory. I recently had a 4-hour evaluation/testing with Dr. Christopher Cranston of JHU. He prepared a detailed report and says I should explore clinical trials.
PatientReceived 1 prior treatment
I have had trouble remembering names of acquaintances and others that I know their names but sometimes forger. My wife says my memory isn’t what it used to be.
PatientReceived 1 prior treatment
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