JNJ-63733657 for Alzheimer's Disease

(Autonomy Trial)

Not currently recruiting at 155 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JNJ-63733657, an experimental drug, to assess its effects on individuals with early Alzheimer's disease. It compares low and high doses of the medication to a placebo, which contains no active drug. Researchers aim to determine if JNJ-63733657 can slow the decline in memory and daily function. Ideal candidates for the trial have experienced a gradual decline in memory over the past six months and have a positive result on a specialized brain scan for Alzheimer’s. Participants must also have someone to assist them throughout the study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that JNJ-63733657 is safe and well-tolerated in both healthy individuals and those with Alzheimer's disease. Earlier studies found no major safety issues, and participants did not experience serious side effects. This treatment is an antibody targeting tau proteins, which are linked to Alzheimer's. Although this study remains in an early stage, previous testing suggests it is safe for humans at the doses being studied. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Unlike the standard treatments for Alzheimer's disease, which mainly include drugs like donepezil and memantine that focus on managing symptoms, JNJ-63733657 offers a novel approach. This treatment works by targeting specific pathways in the brain, potentially altering the disease's progression rather than just alleviating symptoms. Administered through an intravenous infusion every four weeks, it provides a consistent delivery method that may enhance its effectiveness. Researchers are particularly excited about its potential to make a significant impact on the underlying mechanisms of Alzheimer's, which could change the landscape of treatment options for patients.

What evidence suggests that this trial's treatments could be effective for Alzheimer's Disease?

Research shows that JNJ-63733657, an anti-tau monoclonal antibody, may help treat Alzheimer's disease. Earlier studies found it to be generally safe and well-tolerated in both healthy individuals and those with Alzheimer's. This trial will evaluate JNJ-63733657 in different dosages, with some participants receiving a low dose and others a high dose, to assess its effectiveness in targeting tau. Tau is a protein that forms tangles in the brains of people with Alzheimer's, and targeting it may help slow the disease's progression. The U.S. FDA has given JNJ-63733657 Fast Track Designation, recognizing its potential significance. Early trials showed that reducing tau is linked to positive outcomes, suggesting that JNJ-63733657 could help manage Alzheimer's symptoms. ^{1 2 3 4 6}

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04619420

NCT04619420 | A Study of JNJ-63733657 in Participants ... The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11573813/

Phase 1 Studies of the Anti-Tau Monoclonal Antibody JNJ ... Results. JNJ-63733657 was generally safe and well-tolerated in healthy participants and participants with Alzheimer's disease.

3. jnj.com jnj.com/media-center/press-releases/johnson-johnsons-posdinemab-and-tau-active-immunotherapy-receive-u-s-fda-fast-track-designations-for-the-treatment-of-alzheimers-disease

Johnson & Johnson's Posdinemab and Tau Active ... Johnson & Johnson's Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer's Disease.

4. neurologylive.com neurologylive.com/view/screening-experience-phase-2-autonomy-study-provides-anti-tau-trials-alzheimers

Screening Experience of Phase 2 Autonomy Study ... Key Takeaways · The Autonomy trial used plasma biomarkers for prescreening, linking tau PET SUVr to clinical outcomes in Alzheimer's disease.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1568163724000102

Passive immunotherapy for Alzheimer's disease At 104 weeks, the amyloid levels of 51% of patients were below the positivity threshold. These data suggest a potential clinical benefit of high-dose ...

6. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2020-000116-30/BE

Clinical Trials Register A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, ...