JNJ-63733657 for Alzheimer's Disease
(Autonomy Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new drug called JNJ-63733657 to see if it can help slow down the worsening of symptoms in patients with Alzheimer's disease. The goal is to see if the drug can help maintain brain function and daily living skills better.
Will I have to stop taking my current medications?
The trial requires that any medications affecting the central nervous system (CNS) be stable for at least 2 months before screening, and chronic use of benzodiazepines is not allowed. If you've recently stopped a CNS medication, it must have been discontinued at least 2 months before screening.
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive JNJ-63733657 or placebo administered by IV infusion every 4 weeks during the double-blind treatment period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Extension
Participants may opt into continuation of treatment with JNJ-63733657 during the LTE treatment period
What Are the Treatments Tested in This Trial?
Interventions
- JNJ-63733657
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University