A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
NCT ID: NCT06887192
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2025-08-15
2027-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ML-007C-MA
ML-007C-MA
ML-007C-MA dosed as 105/1.5 mg (one tablet of 105/1.5 mg ML-007C-MA), or 210/3 mg (two tablets of 105/1.5 mg ML-007C-MA )
Placebo
Placebo
Placebo Tablets
Interventions
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ML-007C-MA
ML-007C-MA dosed as 105/1.5 mg (one tablet of 105/1.5 mg ML-007C-MA), or 210/3 mg (two tablets of 105/1.5 mg ML-007C-MA )
Placebo
Placebo Tablets
Eligibility Criteria
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Inclusion Criteria
1. The participant's LAR (or care partner, if local regulations allow) must provide written informed consent AND
2. The participant will provide written (if capable) informed assent.
2. Aged 55 to 90 years, inclusive, at time of informed consent.
3. Meets clinical criteria for Possible AD or Probable AD.
4. Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.
5. Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.
6. 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.
7. 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.
8. Has a (CGI)-S hallucinations and delusions domain-specific score ≥4
9. Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive.
Exclusion Criteria
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 had an amyloid positron emission tomography (PET) brain scan or cerebrospinal fluid (CSF) Alzheimer's disease biomarker test in the past 3 years with results inconsistent with a diagnosis of AD.
6. 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.
7. Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma
8. Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine).
9. Has previously participated in any clinical study with ML-007 or ML-007C-MA.
10. 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).
55 Years
90 Years
ALL
No
Sponsors
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MapLight Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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MapLight Therapeutics
Role: STUDY_DIRECTOR
MapLight Therapeutics
Locations
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Clinical Site
Scottsdale, Arizona, United States
Clinical Site
Tucson, Arizona, United States
Clinical Site
Anaheim, California, United States
Clinical Site
Orange, California, United States
Clinical Site
Boca Raton, Florida, United States
Clinical Site
Deerfield Beach, Florida, United States
Clinical Site
Doral, Florida, United States
Clinical Site
Homestead, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami Gardens, Florida, United States
Clinical Site
Miami Gardens, Florida, United States
Clinical Site
Naples, Florida, United States
Clinical Site
Orlando, Florida, United States
Clinical Site
West Palm Beach, Florida, United States
Clinical Site
Independence, Ohio, United States
Clinical Site
Brampton, Ontario, Canada
Clinical Site
London, Ontario, Canada
Clinical Site
Toronto, Ontario, Canada
Clinical Site
Lévis, Quebec, Canada
Countries
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Central Contacts
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Other Identifiers
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2024-519820-26-00
Identifier Type: CTIS
Identifier Source: secondary_id
ML-007C-MA-221
Identifier Type: -
Identifier Source: org_study_id