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New pill aims to soothe agitation in Alzheimer's patients

NCT ID NCT06803823

Symptom relief Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called ONO-2020 to see if it can safely reduce agitation in people with Alzheimer's disease dementia. About 90 participants in Japan will receive either the drug or a placebo daily for several weeks. Researchers will measure changes in agitation symptoms and monitor for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ONO-2020 (an experimental oral drug)
What this could lead to
If it works, this could provide a new treatment option to reduce agitation in people with Alzheimer's dementia, improving their quality of life and easing caregiver burden.
What could go wrong
This is an early phase 2a trial with only 90 participants in Japan, so results may not apply broadly. The drug may prove no better than placebo, or side effects could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of probable AD according to the diagnostic criteria for AD dementia (NIA-AA 2011) * Mini-Mental State Examination (MMSE) score ≥ 5 to ≤ 22 at the start of the treatment period * Symptoms of agitation defined by the IPA from at least 14 days before the start of the screening period * Neuropsychiatric Inventory-Nursing Home version (NPI-NH) Agitation/Aggression domain (NPI-NH-A/A) score ≥ 4 at the start of the treatment period. * Patients who can participate in the study under hospitalization from 21 days before the start of the treatment period to throughout the treatment period Exclusion Criteria: * Diagnosis of dementia not due to AD or any other disorder with memory impairment, such as mixed dementia, vascular dementia, Lewy body dementia, dementia associated with Parkinson's disease, frontotemporal dementia, drug-induced dementia, dementia associated with human immunodeficiency virus (HIV) infection, traumatic brain injury, normal pressure hydrocephalus, or other non-AD dementia * Any MRI or CT scan of the brain performed after the onset of dementia with findings consistent with clinically relevant CNS disease other than AD, such as vascular changes (eg, cortical cerebral infarction, multiple cerebral infarctions), space-occupying lesions (eg, tumors), or any other major structural brain disease * Delirium within 30 days before the start of the screening period or a history of delirium * At risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) (answers "yes" to Question 4 or 5 of the suicidal ideation section of the C-SSRS) or any suicide attempt within 6 months before the start of the screening period, or at serious risk of suicide in the opinion of the investigator or subinvestigator * Prior or current treatment with anti-amyloid beta antibodies

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Agitation associated with Alzheimer's disease dementia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aburayama Hospital

    RECRUITING

    Fukuoka, Japan

  • Airanomori Hospital

    RECRUITING

    Kagoshima, Japan

  • Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital

    RECRUITING

    Aomori, Japan

  • Akita Prefectural Center For Rehabilitation and Psychiatric Medicine

    RECRUITING

    Akita, Japan

  • Asuka Hospital

    RECRUITING

    Tokyo, Japan

  • Fujisawahospital

    RECRUITING

    Kanagawa, Japan

  • Fukui Hospital

    RECRUITING

    Fukui, Japan

  • Hatano Kousei Hospital

    RECRUITING

    Kanagawa, Japan

  • Hayakawa Clinic

    RECRUITING

    Hiroshima, Japan

  • Hizen Psychiatric Center

    RECRUITING

    Saga, Japan

  • Hosogi Hospital

    RECRUITING

    Kochi, Japan

  • Hotei Hospital

    RECRUITING

    Aichi, Japan

  • Ichiyo Mental Hospital

    RECRUITING

    Kochi, Japan

  • Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba

    RECRUITING

    Miyagi, Japan

  • Ishiki Hospital

    RECRUITING

    Kagoshima, Japan

  • JA-Nagano North Alps Medical Center Azumi Hospital

    RECRUITING

    Nagano, Japan

  • Jizenkai Ando Hospital

    RECRUITING

    Nagano, Japan

  • Keiseikai Hospital

    RECRUITING

    Hokkaido, Japan

  • Kishikai Kishi Hospital

    RECRUITING

    Gunma, Japan

  • Koseikai Cocoro Hospital Kusatsu

    RECRUITING

    Hiroshima, Japan

  • Kuramitsu Hospital

    RECRUITING

    Fukuoka, Japan

  • Maizuru Medical Center

    RECRUITING

    Kyoto, Japan

  • Matsubara Hospital

    RECRUITING

    Fukui, Japan

  • Medical Corporation Keishinkai Kyowa Hospital

    RECRUITING

    Akita, Japan

  • NHO Obihiro National Hospital

    RECRUITING

    Hokkaido, Japan

  • Nagaokai Neyagawa Sanatorium

    RECRUITING

    Osaka, Japan

  • Nakamura Hospital

    RECRUITING

    Hiroshima, Japan

  • Nara Medical University Hospital

    RECRUITING

    Nara, Japan

  • Nishigahara Hospital

    RECRUITING

    Tokyo, Japan

  • Nishiyama Hospital

    RECRUITING

    Kyoto, Japan

  • Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital

    RECRUITING

    Osaka, Japan

  • Rainbow & Sea Hospital

    RECRUITING

    Saga, Japan

  • Saitama Konan Hospital

    RECRUITING

    Saitama, Japan

  • Sansyu Hospital

    RECRUITING

    Kagoshima, Japan

  • Sanyokai Sanyo Hospital

    RECRUITING

    Yamagata, Japan

  • Seinan Hospital

    RECRUITING

    Aomori, Japan

  • Showa Medical University Northern Yokohama Hospital

    RECRUITING

    Kanagawa, Japan

  • Taniyama Hospital

    RECRUITING

    Kagoshima, Japan

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