ONO-2020 for Alzheimer's Disease

Recruiting at 23 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

Trial Summary

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.

What data supports the effectiveness of the drug ONO-2020 for Alzheimer's Disease?

The research suggests that using alternative cognitive, imaging, functional, or composite endpoints, and recruiting patients with Late Mild Cognitive Impairment (LMCI) could improve the success rate of Alzheimer's disease clinical trials, potentially making treatments like ONO-2020 more effective. ^{1 2 3 4 5}

Is ONO-2020 safe for humans?

There is no specific safety data available for ONO-2020, but related compounds like ONO-4007 have been tested in humans. In a study with ONO-4007, some patients experienced side effects like muscle pain, nausea, and low blood pressure, with more severe reactions at higher doses. ^{6 7 8 9 10}

What is the purpose of this trial?

This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess safety, tolerability, pharmacokinetics, and efficacy of ONO-2020 in participants with mild to moderate Alzheimer's disease (AD). This study aims to determine whether administering ONO-2020, an epigenetic regulator, may improve cognitive functions like memory and cognition in individuals with Alzheimer's disease dementia.

Research Team

Project Leader

Principal Investigator

Ono Pharmaceutical Co. Ltd

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Japan pubmed.ncbi.nlm.nih.gov

[Orange Platform]. [2017]

3. 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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Establishing Clinically Meaningful Change on Outcome Assessments Frequently Used in Trials of Mild Cognitive Impairment Due to Alzheimer's Disease. [2023]

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

Validation of the relevant outcome scale for Alzheimer's disease: a novel multidomain assessment for daily medical practice. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The effect of treatment with a sustained-release prostacyclin analogue (ONO-1301-loaded PLGA microsphere) on short-term memory impairment in rats with transient global cerebral ischemia. [2018]

7. France pubmed.ncbi.nlm.nih.gov

New synthesis and promising neuroprotective role in experimental ischemic stroke of ONO-1714. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

Phase I study of ONO-4007, a synthetic analogue of the lipid A moiety of bacterial lipopolysaccharide. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, and Pharmacokinetic Profile of the Novel Translocator Protein 18 kDa Antagonist ONO-2952 in Healthy Volunteers. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Single injection of ONO-1301-loaded PLGA microspheres directly after ischaemia reduces ischaemic damage in rats subjected to middle cerebral artery occlusion. [2018]