Taking people in SlovakiaPhase 2
Tests ML-007C-MA for hallucinations and delusions in Alzheimer's disease psychosis
Tests ML-007C-MA against placebo in people with Alzheimer's psychosis.
Key facts
- Who runs it
- MapLight Therapeutics
- Where
- Vranov nad Topľou, SlovakiaSee the siteAlso in 14 other countries, 74 sites
- Trial code
- Registry title
- A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 300 people, planned
- Started
- 15 Aug 2025
- Expected to end
- Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- ML-007C-MA
- Placebo
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 55 to 90 with Alzheimer's disease who have hallucinations and delusions (psychosis).
- Age
- 55 to 90 years
- Sex
- Men and women
- Disease stage
- Possible or probable Alzheimer's disease with psychotic symptoms for at least 2 months before screening. Hallucinations and delusions must be moderate to severe. NPI-C H+D score of 6 or more. MMSE score of 6 to 26.
- Earlier treatment
- No earlier study with ML-007 or ML-007C-MA. No investigational drug, biological product or device within 90 days before baseline (6 months for investigational Alzheimer's disease-modifying therapies).
- Biomarker or test result
- If an amyloid PET brain scan or CSF Alzheimer's biomarker test was done in the past 3 years, the result must fit Alzheimer's disease.
Main reasons for not taking part
- Under hospice care, bed-bound, or receiving end-of-life palliative care
- Psychotic symptoms mainly caused by substance abuse or a condition other than Alzheimer's disease
- Another brain disorder that is the main cause of the dementia
- Moderate or severe major depressive episode within 3 months of screening
- Alcohol or substance use disorder within the past 12 months
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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:; The participant's LAR must provide written informed consent AND; The participant will provide informed assent
- Meets clinical criteria for Possible AD or Probable AD
- Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening
- Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening
- 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
- Has a NPI-C H+D score of ≥ 6 AND meet at least 1 of the following criteria:; Moderate to severe delusions, defined as NPI-C Delusions domain score of ≥ 2 on at least 2 of the 8 items OR; Moderate to severe hallucinations, defined as NPI-C Hallucinations domain score of ≥ 2 on at least 2 of the 7 items
- Has a (CGI)-S hallucinations and delusions domain-specific score ≥4
- Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive
Who cannot take part
- Under the care of hospice, bed-bound, or receiving end-of-life palliative care
- Has previously participated in any clinical study with ML-007 or ML-007C-MA
- 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)
- Psychotic symptoms that are primarily attributable to substance abuse or a medical, neurological or psychiatric condition other than Alzheimer's disease
- 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
- 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
- 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
- Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine)
- Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients
- Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria
- Has an elevated risk of suicidal behavior
- Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 90 years old?
- Has a doctor told you that you have Alzheimer's disease?
- Do you have hallucinations or delusions caused by Alzheimer's disease?
Where in Slovakia
Also in 14 other countries, 74 sites
- Crystal Comfort S.R.O.Vranov nad Topľou, SlovakiaTaking people
About the trial
What the trial wants to find out
ML-007C-MA-221 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ML-007C-MA in male and female participants aged 55 to 90 years with hallucinations and delusions associated with Alzheimer's Disease Psychosis (ADP).
Read full original descriptionShow less
The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo for the treatment of hallucinations and delusions associated with ADP as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
The 2 groups in the trial
- ML-007C-MATreatment being tested
- PlaceboPlacebo, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis
- Plain-language title
- Tests ML-007C-MA for hallucinations and delusions in Alzheimer's disease psychosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06887192, who can take part
- Record updated
- 12 November 2026