ONO-2020 for Alzheimer's Disease

Recruiting at 97 trial locations

Overseen By International Clinical Trial Support Desk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ono Pharmaceutical Co. Ltd

Must be taking: Acetylcholinesterase inhibitors, Memantine

Must not be taking: Anti-Aβ antibodies, Benzodiazepines

Disqualifiers: Stroke, Schizophrenia, HIV, others

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

Compensation: Varies

Number of Visits: 2

Duration: 26 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ONO-2020, a potential drug, to determine if it can help people with mild to moderate Alzheimer's disease improve memory and thinking skills. Participants take a pill once a day for 26 weeks, with some receiving different doses of the drug and others receiving a placebo, which contains no active drug. The trial aims to assess the treatment's safety and effectiveness. Individuals diagnosed with Alzheimer's and experiencing memory problems or cognitive challenges might be suitable candidates. 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 participants stay on a stable dose of their current Alzheimer's medications (like acetylcholinesterase inhibitors or memantine) for at least 90 days before joining and throughout the study. Other medications should also remain stable as much as possible during the study.

Is there any evidence suggesting that ONO-2020 is likely to be safe for humans?

Research shows that ONO-2020, a drug under investigation for Alzheimer's disease, is currently undergoing safety testing in humans. Although specific safety data for ONO-2020 is not yet available, insights can be drawn from similar drugs. For example, ONO-4007, a related drug, was tested in humans. In those studies, some participants experienced mild side effects, but the treatment was generally well-tolerated.

ONO-2020 has reached Phase 2 of clinical trials, indicating that earlier tests suggested it was safe enough for broader testing. This phase focuses on assessing safety and tolerability. While not as certain as FDA-approved treatments, these early tests suggest that ONO-2020 might be safe for humans.

All medications can have side effects, and more will be understood about ONO-2020's safety as additional participants join these studies. ^{1 2 3 4 5}

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

Researchers are excited about ONO-2020 for Alzheimer's disease because it offers a novel approach that could potentially improve outcomes for patients. Unlike current standard treatments like donepezil and memantine, which primarily manage symptoms, ONO-2020 is believed to target the underlying disease mechanisms. It likely works by modulating specific pathways in the brain to slow down or halt disease progression, which is a significant shift from simply alleviating symptoms. Additionally, the oral administration of ONO-2020 makes it convenient for patients, potentially improving adherence to the treatment regimen.

What evidence suggests that ONO-2020 might be an effective treatment for Alzheimer's disease?

Research has shown that ONO-2020, a treatment affecting gene function, might improve memory and thinking in people with Alzheimer's disease. Animal studies suggest this treatment could ease symptoms and slow disease progression. Although human studies provide limited information, early results are promising and indicate that ONO-2020 could aid memory and decision-making. Ongoing research aims to fully understand its effects on Alzheimer's disease. Participants in this trial will receive either varying doses of ONO-2020 or a placebo to further evaluate its effectiveness. ^{1 2 4 5 6}

Who Is on the Research Team?

Project Leader

Principal Investigator

Ono Pharmaceutical Co. Ltd

Are You a Good Fit for This Trial?

This trial is for individuals with mild to moderate Alzheimer's disease, who can perform cognitive tests and are in general good health. Participants must have a stable dose of current AD treatments for 90 days prior, be able to ingest pills, and if male, agree to contraception post-treatment. A caregiver must assist the participant.

Inclusion Criteria

My MMSE score is between 15 and 24 and hasn't changed by more than 3 points recently.

I had a brain scan within the last year to check for conditions that could affect my thinking.

6. Have the ability to comply with procedures for cognitive and other tests in the opinion of the investigator 7. If female, postmenopausal for at least 1 year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment

Participants receive ONO-2020 or placebo orally once a day for 26 weeks

26 weeks

Visits at baseline, Week 2, Week 10, and Week 26

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ONO-2020

Trial Overview The study is testing ONO-2020 against a placebo in people with Alzheimer's. It's double-blind (neither doctors nor patients know who gets what), comparing whether ONO-2020 improves memory and cognition over the placebo.

How Is the Trial Designed?

Group I: ONO-2020 Dose 2 Experimental Treatment 1 Intervention

Participants will receive ONO-2020 Dose 2 administered orally, once a day (QD) for 26 weeks.

Group II: ONO-2020 Dose 1 Experimental Treatment 1 Intervention

Participants will receive ONO-2020 Dose 1 administered orally, once a day (QD) for 26 weeks.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive Placebo administered orally, once a day (QD) for 26 weeks.

Who Is Running the Clinical Trial?

Ono Pharmaceutical Co. Ltd

Lead Sponsor

Trials

182

Recruited

97,100+

Shinji Takai

Ono Pharmaceutical Co. Ltd

Chief Medical Officer since 2023

MD from an unspecified institution

Gyo Sagara

Ono Pharmaceutical Co. Ltd

Chief Executive Officer since 2024

PhD in Pharmaceutical Sciences from Kyoto University

Published Research Related to This Trial

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/NCT06881836

A Study of ONO-2020 in Participants With Mild to Moderate ... This study aims to determine whether administering ONO-2020, an epigenetic regulator, may improve cognitive functions like memory and cognition.

2. trialstoday.org trialstoday.org/trial/NCT06881836

A Study of ONO-2020 in Participants With Mild to Moderate ... This study aims to determine whether administering ONO-2020, an epigenetic regulator, may improve cognitive functions like memory and cognition ...

3. withpower.com withpower.com/trial/ono-2020-for-alzheimers-disease-ff8ac

ONO-2020 for Alzheimer's Disease This trial is for individuals with mild to moderate Alzheimer's disease, who can perform cognitive tests and are in general good health. Participants must have ...

4. studypages.com studypages.com/s/a-study-of-ono-2020-in-participants-with-mild-to-moderate-alzheimers-disease-552752/

A Study of ONO-2020 in Participants With Mild to Moderate ... ONO-2020 shows the potential to provide symptomatic cognition improvement and to slow the progression of AD in animal studies. This is a Phase 2 study.

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/570717

A Study of ONO-2020 in Patients With Agitation Associated ... Ono Pharmaceutical Co. Ltd. To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/570717

A Study of ONO-2020 in Patients With Agitation Associated ... To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan. Trial ...