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New pill aims to quiet Alzheimer's psychosis

NCT ID NCT06887192

Symptom relief Sponsor: MapLight Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 4 times

Summary

This Phase 2 study tests an experimental drug, ML-007C-MA, to see if it can safely reduce hallucinations and delusions in people with Alzheimer's disease. About 300 participants aged 55 to 90 will receive either the drug or a placebo. The main goal is to measure changes in psychotic symptoms using a standard clinician rating scale.

What this could mean

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

Active substance
ML-007C-MA (a combination drug taken as a tablet)
What this could lead to
If it works, this could offer a new option to reduce troubling hallucinations and delusions in people with Alzheimer's disease, improving their quality of life.
What could go wrong
This is an early Phase 2 trial with only 300 participants, so results may not confirm benefit. The drug may cause side effects or work no better than a placebo.

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 300 people

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

Started

Aug 2025

Expected to finish

Dec 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.

Key Inclusion Criteria: 1. Willing and able to provide written informed consent, or, if deemed lacking in the capacity to provide informed consent, the following requirements for consent must be met: 1. The participant's LAR must provide written informed consent AND 2. The participant will provide informed assent. 2. Meets clinical criteria for Possible AD or Probable AD. 3. Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening. 4. Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening. 5. Has a designated care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug. 6. Has a NPI-C H+D score of ≥ 6 AND meet at least 1 of the following criteria: 1. Moderate to severe delusions, defined as NPI-C Delusions domain score of ≥ 2 on at least 2 of the 8 items OR 2. Moderate to severe hallucinations, defined as NPI-C Hallucinations domain score of ≥ 2 on at least 2 of the 7 items. 7. Has a (CGI)-S hallucinations and delusions domain-specific score ≥4 8. Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive. Key Exclusion Criteria: 1. Under the care of hospice, bed-bound, or receiving end-of-life palliative care. 2. Psychotic symptoms that are primarily attributable to substance abuse or a medical, neurological or psychiatric condition other than Alzheimer's disease. 3. Evidence of a CNS disorder other than Alzheimer's disease that is the primary cause of, or a significant contributor to the participant's dementia. 4. Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria. 5. Has an elevated risk of suicidal behavior 6. Has had an amyloid PET brain scan or CSF Alzheimer's disease biomarker test in the past 3 years with results inconsistent with a diagnosis of AD. 7. Evidence of a clinically significant and/or unstable medical condition that, in the opinion of the investigator or medical monitor, could substantially impair cognition, compromise participant safety, interfere with the participant's ability to comply with study procedures or substantially impair the evaluation of efficacy or safety assessments. 8. Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma 9. Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine). 10. Has previously participated in any clinical study with ML-007 or ML-007C-MA. 11. Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients. 12. Received or may have received an investigational drug, biological product or device within 90 days before Baseline (or 6 months for investigational Alzheimer's disease-modifying therapies).

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Conditions

The condition(s) this trial relates to.

Alzheimer disease brain disorder central nervous system disorder cognitive disorder Delusions dementia Hallucinations nervous system disorder neurodegenerative disease psychiatric disorder Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders tauopathy

As listed by the trial registrant

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

Psychosis associated with Alzheimer's disease

How to take part

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

  1. The places running it

    55 sites in 14 countries. 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

  • Clinical Site

    RECRUITING

    Phoenix, Arizona, 85004, United States

  • Clinical Site

    RECRUITING

    Scottsdale, Arizona, 85253, United States

  • Clinical Site

    RECRUITING

    Tucson, Arizona, 85704, United States

  • Clinical Site

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    Anaheim, California, 92805, United States

  • Clinical Site

    RECRUITING

    Long Beach, California, 90807, United States

  • Clinical Site

    RECRUITING

    Murrieta, California, 92562, United States

  • Clinical Site

    RECRUITING

    Orange, California, 92866, United States

  • Clinical Site

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    San Diego, California, 92123, United States

  • Clinical Site

    RECRUITING

    Denver, Colorado, 80218, United States

  • Clinical Site

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    Boca Raton, Florida, 33428, United States

  • Clinical Site

    RECRUITING

    Deerfield Beach, Florida, 33442, United States

  • Clinical Site

    RECRUITING

    Doral, Florida, 33122, United States

  • Clinical Site

    RECRUITING

    Homestead, Florida, 33033, United States

  • Clinical Site

    RECRUITING

    Miami, Florida, 33122, United States

  • Clinical Site

    RECRUITING

    Miami, Florida, 33155, United States

  • Clinical Site

    RECRUITING

    Miami, Florida, 33173, United States

  • Clinical Site

    RECRUITING

    Miami, Florida, 33186, United States

  • Clinical Site

    RECRUITING

    Miami Gardens, Florida, 33014, United States

  • Clinical Site

    RECRUITING

    Miami Gardens, Florida, 33104, United States

  • Clinical Site

    RECRUITING

    Naples, Florida, 34105, United States

  • Clinical Site

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    Orlando, Florida, 32807, United States

  • Clinical Site

    RECRUITING

    Tampa, Florida, 33629, United States

  • Clinical Site

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Clinical Site

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Clinical Site

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    Snellville, Georgia, 30078, United States

  • Clinical Site

    RECRUITING

    Las Vegas, Nevada, 89121, United States

  • Clinical Site

    RECRUITING

    West Long Branch, New Jersey, 07764, United States

  • Clinical Site

    RECRUITING

    Dayton, Ohio, 45459, United States

  • Clinical Site

    RECRUITING

    Independence, Ohio, 44131, United States

  • Clinical Site

    RECRUITING

    Tigard, Oregon, 97223, United States

  • Clinical Site

    RECRUITING

    Austin, Texas, 78757, United States

  • Clinical Site

    RECRUITING

    McKinney, Texas, 75071, United States

  • Clinical Site

    RECRUITING

    Sugarland, Texas, 77478, United States

  • Clinical Site

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Clinical Site

    RECRUITING

    Córdoba, Córdoba Province, X5009BIN, Argentina

  • Clinical Site

    RECRUITING

    Córdoba, X5004AOA, Argentina

  • Clinical Site

    RECRUITING

    Pernik, Pernik, 2304, Bulgaria

  • Clinical Site

    RECRUITING

    Sofia, Sofia, 1408, Bulgaria

  • Clinical Site

    NOT_YET_RECRUITING

    Brampton, Ontario, L6W 2Z8, Canada

  • Clinical Site

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Clinical Site

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Clinical Site

    RECRUITING

    Lévis, Quebec, G6V 0C9, Canada

  • Clinical Site

    RECRUITING

    Choceň, 565 01, Czechia

  • Clinical Site

    RECRUITING

    Prague, 150 00, Czechia

  • Clinical Site

    RECRUITING

    Toulouse, 31059, France

  • Clinical Site

    RECRUITING

    Pécs, 7623, Hungary

  • Clinical Site

    RECRUITING

    Pécs, 7633, Hungary

  • Clinical Site

    RECRUITING

    Roma, 00128, Italy

  • Clinical Site

    RECRUITING

    Plewiska, 62-064, Poland

  • Clinical Site

    RECRUITING

    Torres Vedras, Lisbon District, 2560-280, Portugal

  • Clinical Site

    RECRUITING

    Bucharest, 041914, Romania

  • Clinical Site

    RECRUITING

    Kragujevac, 34000, Serbia

  • Clinical Site

    RECRUITING

    Vranov nad Topľou, 093 01, Slovakia

  • Clinical Site

    RECRUITING

    Daegu, 41404, South Korea

  • Clinical Site

    RECRUITING

    Incheon, 21565, South Korea

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