JNJ-63733657 for Alzheimer's Disease

(Autonomy Trial)

Recruiting at 143 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must be taking: AD treatments

Must not be taking: Benzodiazepines, CNS medications

Disqualifiers: MCI, Parkinson's, Alcohol abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 26

Duration: 104 weeks

523 Participants Needed

Trial Summary

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.

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.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

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.

You need to have a positive tau PET scan result.

Exclusion Criteria

Your Hachinski Ischemic Scale score is more than 4.

I have been diagnosed with MCI or dementia not caused by Alzheimer's.

My CNS medication has been stable for 2 months, and I don't use benzodiazepines.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-63733657 or placebo administered by IV infusion every 4 weeks during the double-blind treatment period

104 weeks

26 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Extension

Participants may opt into continuation of treatment with JNJ-63733657 during the LTE treatment period

Up to 245 weeks

Treatment Details

Interventions

• JNJ-63733657
• Placebo

Trial Overview 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.

Participant Groups

Group I: JNJ-63733657 Low-dose Experimental Treatment 1 Intervention

Participants will receive single dose of JNJ-63733657 low-dose administered by intravenous (IV) infusion every 4 weeks during the double-blind treatment period. Participants will have an option to continue with the long-term extension (LTE) phase of the trial and will continue to receive the same treatment and dose during the LTE treatment period.

Group II: JNJ-63733657 High-dose Experimental Treatment 1 Intervention

Participants will receive single dose of JNJ-63733657 high-dose administered by IV infusion every 4 weeks during double-blind treatment period. Participants will have an option to continue with the LTE phase of the trial and will continue to receive the same treatment and dose during the LTE treatment period.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive single dose of matching placebo to JNJ-63733657 administered by IV infusion every 4 weeks during double-blind treatment period. Participants will have an option to continue with the LTE phase of the trial and will be re-randomized in a 1:1 ratio to receive either JNJ-63733657 low-dose or JNJ-63733657 high-dose during the LTE treatment period.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

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