JNJ-64042056 for Alzheimer's Disease

(Reτain Trial)

Recruiting at 103 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Pharmaceutica N.V., Belgium

Disqualifiers: Alzheimer's Dementia, Mild Cognitive Impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 180 weeks

498 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JNJ-64042056, an experimental therapy, to determine if it can slow memory and thinking problems in individuals at risk for Alzheimer's disease. Participants will receive either the treatment or a placebo, a substance with no active drug. The trial seeks individuals showing early signs of Alzheimer's risk, such as elevated tau protein in the brain, a marker linked to Alzheimer's, but who do not yet have symptoms. Those without memory issues but with a special brain scan indicating increased tau levels might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that JNJ-64042056 is likely to be safe for humans?

Research has shown that JNJ-64042056 was well tolerated in earlier studies. Participants received various doses, and the treatment did not cause major negative effects, suggesting it is generally safe. However, side effects can still occur, and individual reactions may vary. Researchers continue to study this treatment to fully understand its safety profile. ^{1 2 3 4 5}

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

JNJ-64042056 is unique because it offers a new approach to treating Alzheimer's disease by using an intramuscular injection, which might provide a more consistent delivery method compared to oral medications. Most current treatments, like cholinesterase inhibitors and memantine, focus on managing symptoms, but JNJ-64042056 is designed to target the underlying disease processes more directly. Researchers are excited because this treatment has the potential to slow down the progression of Alzheimer’s, which is a significant step forward compared to just alleviating symptoms.

What evidence suggests that JNJ-64042056 might be an effective treatment for Alzheimer's?

Research shows that JNJ-64042056, which participants in this trial may receive, targets a protein called tau, involved in the development of Alzheimer’s Disease. Studies with previous patients have shown that treatments focusing on tau proteins can help slow memory and thinking problems. Early results suggest that JNJ-64042056 is generally well tolerated and might delay the onset of Alzheimer’s symptoms. The FDA has given special recognition to the treatment, indicating its potential benefits. While no guarantees exist, the scientific theory behind JNJ-64042056 suggests it might help manage Alzheimer’s by slowing the disease's progression. ^{1 2 3 4 5}

Who Is on the Research Team?

Janssen Pharmaceutica N.V., Belgium Clinical trial

Principal Investigator

Janssen Pharmaceutica N.V., Belgium

Are You a Good Fit for This Trial?

This trial is for individuals who are at risk of developing Alzheimer's disease but do not yet show symptoms (preclinical). Participants should be in good general health and have certain biomarkers indicating a high likelihood of progressing to Alzheimer's.

Inclusion Criteria

Clinical Dementia Rating (CDR) global score of 0 at screening and baseline

Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening

A participant must be of non-childbearing potential

Exclusion Criteria

Vitamin B12 or folate levels below the central laboratory lower limit of normal, unless in the opinion of the investigator it does not require treatment

I have been diagnosed with a form of dementia, such as Alzheimer's, FTD, or Lewy Body.

I have been diagnosed with Mild Cognitive Impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intramuscular (IM) injection of JNJ-64042056 or placebo from Week 0 until Week 180

180 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-64042056

Trial Overview The study tests the effects of JNJ-64042056 on preventing cognitive decline compared to a placebo. Cognitive function will be measured using the PACC-5 scale, which assesses memory and thinking skills.

How Is the Trial Designed?

Group I: Arm A: JNJ-64042056 Experimental Treatment 1 Intervention

Participants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 until Week 180.

Group II: Arm B: Placebo Placebo Group 1 Intervention

Participants will receive IM injection of placebo from Week 0 until Week 180.

Who Is Running the Clinical Trial?

Janssen Pharmaceutica N.V., Belgium

Lead Sponsor

Trials

84

Recruited

31,600+

Joaquin Duato

Janssen Pharmaceutica N.V., Belgium

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Pharmaceutica N.V., Belgium

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

The Alzheimer's Disease Neuroimaging Initiative (ADNI) has significantly enhanced the understanding of Alzheimer's disease progression and improved the efficiency of clinical trials through the analysis of data from 1459 publications, including 291 impactful studies from 2021 to 2022.

Promising plasma biomarkers, such as phosphorylated tau, have been identified for clinical use, and the studies highlight the importance of neuroinflammation and the biological heterogeneity of Alzheimer's disease, which is influenced by genetic and vascular factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Alzheimer's Disease Neuroimaging Initiative in the era of Alzheimer's disease treatment: A review of ADNI studies from 2021 to 2022. Veitch, DP., Weiner, MW., Miller, M., et al.[2023]

In a study of 611 Alzheimer's disease patients treated with acetylcholinesterase inhibitors, significant cognitive and functional decline was observed after 6 and 18 months, indicating disease progression.

The results suggest that 6-month follow-ups are not adequate to assess the impact of new treatments, while 18-month follow-ups provide a clearer opportunity to evaluate the efficacy of new Alzheimer's drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six and 18-month changes in mild to moderate Alzheimer's patients treated with acetylcholinesterase inhibitors: what can we learn for clinical outcomes of therapeutic trials? Cortes, F., Portet, F., Touchon, J., et al.[2019]

Current drugs approved for Alzheimer's disease primarily address symptoms rather than modifying the underlying disease mechanisms, highlighting a gap in treatment efficacy.

There is growing interest in developing disease-modifying treatments for Alzheimer's, with proposed clinical trial designs and the use of surrogate markers like brain imaging to better assess their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evaluation of disease modifying therapies in Alzheimer's disease: a regulatory viewpoint. Mani, RB.[2019]

Cholinesterase inhibitors and possibly vitamin E are supported by good evidence for symptomatic treatment of Alzheimer's disease, indicating their efficacy in managing symptoms.

While estrogen and anti-inflammatory agents show potential, there is insufficient evidence to recommend their routine use, highlighting the need for further research in disease modification strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New drugs for Alzheimer's disease and other dementias. Bullock, R.[2019]

The study identified that using the Functional Activities Questionnaire and the Clinical Dementia Rating Sum of Boxes as endpoints can detect significant changes in Alzheimer's disease progression, particularly in patients with Late Mild Cognitive Impairment, suggesting these measures are effective for future trials.

Composite measures showed even greater sensitivity, indicating that using a combination of endpoints could enhance the success rate of Alzheimer's clinical trials by better capturing the disease's progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of endpoint selection: How effective does a drug need to be for success in a clinical trial of a possible Alzheimer's disease treatment? Evans, S., McRae-McKee, K., Wong, MM., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06544616

NCT06544616 | A Study of JNJ-64042056 in Participants ... The purpose of this study is to assess the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 ( ...

2. ir.acimmune.com ir.acimmune.com/news-releases/news-release-details/peer-reviewed-results-phase-1b2a-trial-anti-ptau-active

Peer-reviewed results from Phase 1b/2a Trial of Anti-pTau ... Andrea Pfeifer , CEO of AC Immune SA , commented: “These data show that ACI-35.030 (JNJ-2056) was well tolerated at all tested doses and induced ...

3. isrctn.com isrctn.com/ISRCTN78730935

A study of JNJ-64042056 in participants with preclinical ... Based on scientific theory, taking JNJ-64042056 may slow Alzheimer's Disease progression and delay symptom onset. However, this cannot be guaranteed because ...

4. 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.

5. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(25)00384-6/fulltext

Safety and immunogenicity of two Tau-targeting active ... ACI-35.030 and JACI-35.054 are active immunotherapies being developed for the treatment of Alzheimer's Disease (AD). ACI-35.030 and JACI-35.054 are designed to ...