Actively Recruiting
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
Led by MapLight Therapeutics · Updated on 2026-05-19
300
Participants Needed
40
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of ML-007C-MA in people aged 55 to 90 years who have hallucinations and delusions linked to Alzheimer's Disease Psychosis (ADP). This Phase 2, randomized, double-blind, placebo-controlled study aims to compare ML-007C-MA with a placebo to see if it can improve symptoms as measured by a specific clinical score for hallucinations and delusions. Participants receive either ML-007C-MA at doses of 105/1.5 mg twice daily or 210/3 mg twice daily, or a placebo tablet, during the treatment period. The study uses a randomized assignment and blinding to ensure unbiased evaluation of treatment effects. The treatment period lasts seven weeks, after which outcomes are assessed. During the study, participants will undergo assessments including the Neuropsychiatric Inventory-Clinician (NPI-C) score for hallucinations and delusions, Clinical Global Impressions-Severity (CGI-S) scores, and evaluations of agitation and aggression if present. Researchers will monitor symptom changes from the start to the end of treatment. Safety and adherence will be tracked throughout, with the total participation lasting at least seven weeks.
CONDITIONS
Brief Title
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent or, if lacking capacity, have a legally authorized representative provide consent and participant assent
- Meets clinical criteria for Possible or Probable Alzheimer's Disease
- Has psychotic symptoms (hallucinations or delusions) for at least 2 months before screening
- Has lived at the same home or care facility for at least 6 weeks before screening
- Has a designated care partner in frequent contact to report symptoms and adherence
- Has a Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score of 6 or higher and moderate to severe delusions or hallucinations as defined by specific domain scores
- Has a Clinical Global Impressions-Severity hallucinations and delusions score of 4 or higher
- Has a Mini-Mental State Examination score between 6 and 26 inclusive
You will not qualify if you...
- Receiving hospice care, bed-bound, or in end-of-life palliative care
- Psychotic symptoms primarily due to substance abuse or other medical, neurological, or psychiatric conditions unrelated to Alzheimer's disease
- Evidence of central nervous system disorders other than Alzheimer's disease as the main cause or significant contributor to dementia
- Moderate or severe major depressive episode within 3 months before screening
- Elevated risk of suicidal behavior
- Recent amyloid PET brain scan or cerebrospinal fluid Alzheimer's biomarker test inconsistent with Alzheimer's diagnosis within past 3 years
- Significant or unstable medical conditions that could impair cognition, safety, compliance, or assessment
- Gastric retention, urinary retention, or narrow-angle glaucoma
- Alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine)
- Previous participation in any study with ML-007 or ML-007C-MA
- Allergy or intolerance to ML-007C-MA or its ingredients
- Received investigational drugs, biological products, or devices within 90 days before baseline or within 6 months for investigational Alzheimer's therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 weeks
Participants receive either the study drug ML-007C-MA or placebo to treat hallucinations and delusions associated with Alzheimer's disease psychosis.
Visits occur at baseline and at the end of treatment
Trial Site Locations
Total: 40 locations
1
Clinical Site
Phoenix, Arizona, United States, 85004
Actively Recruiting
2
Clinical Site
Scottsdale, Arizona, United States, 85253
Actively Recruiting
3
Clinical Site
Tucson, Arizona, United States, 85704
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4
Clinical Site
Anaheim, California, United States, 92805
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5
Clinical Site
Orange, California, United States, 92866
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6
Clinical Site
San Diego, California, United States, 92123
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7
Clinical Site
Boca Raton, Florida, United States, 33428
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8
Clinical Site
Deerfield Beach, Florida, United States, 33442
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9
Clinical Site
Doral, Florida, United States, 33122
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10
Clinical Site
Homestead, Florida, United States, 33033
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11
Clinical Site
Miami, Florida, United States, 33122
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12
Clinical Site
Miami, Florida, United States, 33155
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13
Clinical Site
Miami, Florida, United States, 33173
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14
Clinical Site
Miami, Florida, United States, 33186
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15
Clinical Site
Miami Gardens, Florida, United States, 33014
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16
Clinical Site
Miami Gardens, Florida, United States, 33104
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17
Clinical Site
Naples, Florida, United States, 34105
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18
Clinical Site
Orlando, Florida, United States, 32807
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19
Clinical Site
Tampa, Florida, United States, 33629
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20
Clinical Site
West Palm Beach, Florida, United States, 33407
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21
Clinical Site
Augusta, Georgia, United States, 30912
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22
Clinical Site
Las Vegas, Nevada, United States, 89121
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23
Clinical Site
West Long Branch, New Jersey, United States, 07764
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24
Clinical Site
Dayton, Ohio, United States, 45459
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25
Clinical Site
Independence, Ohio, United States, 44131
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26
Clinical Site
Sugarland, Texas, United States, 77478
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27
Clinical Site
Bellevue, Washington, United States, 98007
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28
Clinical Site
Córdoba, Córdoba Province, Argentina, X5009BIN
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29
Clinical Site
Córdoba, Argentina, X5004AOA
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30
Clinical Site
Pernik, Pernik, Bulgaria, 2304
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31
Clinical Site
Sofia, Sofia, Bulgaria, 1408
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32
Clinical Site
Brampton, Ontario, Canada, L6W 2Z8
Not Yet Recruiting
33
Clinical Site
London, Ontario, Canada, N6A 5W9
Actively Recruiting
34
Clinical Site
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
35
Clinical Site
Lévis, Quebec, Canada, G6V 0C9
Actively Recruiting
36
Clinical Site
Choceň, Czechia, 565 01
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37
Clinical Site
Toulouse, France, 31059
Actively Recruiting
38
Clinical Site
Bucharest, Romania, 041914
Actively Recruiting
39
Clinical Site
Daegu, South Korea, 41404
Actively Recruiting
40
Clinical Site
Incheon, South Korea, 21565
Actively Recruiting
Research Team
C
Clinical Trials Contact Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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