What side effects are associated with this type of intervention?

Common side effects of anti-amyloid beta monoclonal antibodies, such as those similar to JNJ-63733657, include infusion-related reactions, which can manifest as fever, chills, rash, and headache. Other potential side effects are amyloid-related imaging abnormalities (ARIA), which may present as brain swelling or small brain bleeds. General side effects of Alzheimer's treatments can also include gastrointestinal issues, dizziness, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, including anti-amyloid beta monoclonal antibodies. One notable example is aducanumab, which targets amyloid plaques in the brain, a hallmark of Alzheimer's pathology. Aducanumab was approved based on its ability to reduce amyloid plaques, although its clinical efficacy in improving cognitive function has been debated. Other treatments for Alzheimer's Disease include cholinesterase inhibitors like donepezil and NMDA receptor antagonists like memantine, which help manage symptoms but do not modify the disease process.

What other types of research exist?

Promising novel alternatives to JNJ-63733657 for Alzheimer's Disease patients include other anti-amyloid beta monoclonal antibodies such as aducanumab and lecanemab, as well as tau protein inhibitors like semorinemab. Additionally, BACE inhibitors and other emerging therapies targeting different pathways involved in Alzheimer's pathology may also be considered.

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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

Must not have

Participants with CDR GS >=2 at predose baseline Clinical Dementia Rating (CDR) administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and up to 4.5 years (end of treatment)

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been experiencing a slow decline in my memory and thinking skills for the past 6 months.

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I have been experiencing a slow decline in my memory and thinking skills for the past 6 months.

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I have early Alzheimer's with worsening memory over the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My dementia rating is 2 or higher.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to 4.5 years (end of treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score at Week 104

Secondary study objectives

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 more

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 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-doseExperimental Treatment1 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: PlaceboPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JNJ-63733657

2017

Completed Phase 1

~110

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Anti-amyloid beta monoclonal antibodies, such as JNJ-63733657, target and bind to amyloid-beta plaques in the brain, facilitating their removal. This mechanism is crucial because amyloid-beta accumulation is a hallmark of Alzheimer's Disease and is associated with cognitive decline. By reducing these plaques, these treatments aim to slow the progression of cognitive impairment, offering hope for improved quality of life and delayed disease progression for Alzheimer's patients.