JNJ-64042056 for Alzheimer's Disease

(Reτain Trial)

Recruiting at 83 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

Trial Summary

What is the purpose of this trial?

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 (PACC-5) compared with placebo.

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.

What data supports the effectiveness of the drug JNJ-64042056 for Alzheimer's Disease?

The research highlights the importance of selecting the right measures to detect changes in Alzheimer's patients, suggesting that using composite measures and recruiting patients with Late Mild Cognitive Impairment could improve trial success. This implies that the effectiveness of JNJ-64042056 might be better assessed with these strategies, although direct evidence for this specific drug is not provided. ^{1 2 3 4 5}

Research Team

Janssen Pharmaceutica N.V., Belgium Clinical trial

Principal Investigator

Janssen Pharmaceutica N.V., Belgium

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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

Biljana Naumovic

Janssen Pharmaceutica N.V., Belgium

Chief Medical Officer since 2019

MD from Belgrade University Medical School, Executive Education from London Business School

Findings from Research

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]

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]

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]

References

1. United States 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. [2023]

2. France 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? [2019]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Netherlands 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? [2019]

5. England pubmed.ncbi.nlm.nih.gov

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