Actively Recruiting
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
Led by MapLight Therapeutics · Updated on 2026-03-09
300
Participants Needed
26
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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). 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.
CONDITIONS
Official 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 have a legally authorized representative provide consent with 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 prior to screening
- Has a designated care partner in frequent contact to report symptoms and medication adherence
- Has a Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score of 6 or higher and either moderate to severe delusions or hallucinations as defined by specific domain scores
- Has a Clinical Global Impression-Severity score of 4 or higher for hallucinations and delusions
- Has a Mini-Mental State Examination score between 6 and 26 inclusive
You will not qualify if you...
- Under hospice care, bed-bound, or receiving end-of-life palliative care
- Psychotic symptoms primarily due to substance abuse or other medical, neurological, or psychiatric conditions besides Alzheimer's disease
- Presence of a central nervous system disorder other than Alzheimer's disease causing or contributing to dementia
- Moderate or severe major depressive episode within 3 months of screening
- Elevated risk of suicidal behavior
- Amyloid PET brain scan or cerebrospinal fluid Alzheimer's biomarker test within 3 years inconsistent with Alzheimer's diagnosis
- Clinically significant or unstable medical condition impairing cognition or safety or interfering with study compliance
- 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 clinical study involving ML-007 or ML-007C-MA
- Allergy or intolerance to ML-007C-MA or its ingredients
- Received investigational drugs or devices within 90 days before baseline (6 months for Alzheimer's disease-modifying therapies)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 26 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
Actively Recruiting
4
Clinical Site
Anaheim, California, United States, 92805
Actively Recruiting
5
Clinical Site
Orange, California, United States, 92866
Actively Recruiting
6
Clinical Site
San Diego, California, United States, 92123
Actively Recruiting
7
Clinical Site
Boca Raton, Florida, United States, 33428
Actively Recruiting
8
Clinical Site
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
9
Clinical Site
Doral, Florida, United States, 33122
Actively Recruiting
10
Clinical Site
Homestead, Florida, United States, 33033
Actively Recruiting
11
Clinical Site
Miami, Florida, United States, 33122
Actively Recruiting
12
Clinical Site
Miami, Florida, United States, 33155
Actively Recruiting
13
Clinical Site
Miami, Florida, United States, 33173
Actively Recruiting
14
Clinical Site
Miami, Florida, United States, 33186
Actively Recruiting
15
Clinical Site
Miami Gardens, Florida, United States, 33014
Actively Recruiting
16
Clinical Site
Miami Gardens, Florida, United States, 33104
Actively Recruiting
17
Clinical Site
Naples, Florida, United States, 34105
Actively Recruiting
18
Clinical Site
Orlando, Florida, United States, 32807
Actively Recruiting
19
Clinical Site
West Palm Beach, Florida, United States, 33407
Actively Recruiting
20
Clinical Site
Las Vegas, Nevada, United States, 89121
Actively Recruiting
21
Clinical Site
West Long Branch, New Jersey, United States, 07764
Actively Recruiting
22
Clinical Site
Independence, Ohio, United States, 44131
Actively Recruiting
23
Clinical Site
Brampton, Ontario, Canada, L6W 2Z8
Not Yet Recruiting
24
Clinical Site
London, Ontario, Canada, N6A 5W9
Actively Recruiting
25
Clinical Site
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
26
Clinical Site
Lévis, Quebec, Canada, G6V 0C9
Actively Recruiting
Research Team
C
Clinical Trials Contact Center
CONTACT
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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