Psychosis Associated With Alzheimer's DiseasePhase 2NCT06887192
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
A Phase 2 study testing ML-007C-MA in people with Psychosis Associated With Alzheimer's Disease, run by MapLight Therapeutics at 62 sites in 15 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Psychosis Associated With Alzheimer's Disease
- What is being tested?
- ML-007C-MA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 62 sitesin 15 countries
- Study dates
- 15 Aug 2025to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 join
- Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
- 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.
- Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria.
- Has an elevated risk of suicidal behavior
- 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.
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- 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.
- Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma
- Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine).
- Has previously participated in any clinical study with ML-007 or ML-007C-MA.
- Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients.
- 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).
Trial locations and contacts
62 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
62 sites in 15 countries
United States37 sites, 37 recruiting
- Recruiting
Clinical Site
Alexandria, Louisiana, 71301
- Recruiting
Clinical Site
Anaheim, California, 92805
- Recruiting
Clinical Site
Augusta, Georgia, 30912
- Recruiting
Clinical Site
Austin, Texas, 78757
- Recruiting
Clinical Site
Bellevue, Washington, 98007
- Recruiting
Clinical Site
Boca Raton, Florida, 33428
- Recruiting
Clinical Site
Dayton, Ohio, 45459
- Recruiting
Clinical Site
Deerfield Beach, Florida, 33442
- Recruiting
Clinical Site
Denver, Colorado, 80218
- Recruiting
Clinical Site
Doral, Florida, 33122
- Recruiting
Clinical Site
Homestead, Florida, 33033
- Recruiting
Clinical Site
Independence, Ohio, 44131
- Recruiting
Clinical Site
Las Vegas, Nevada, 89121
- Recruiting
Clinical Site
Long Beach, California, 90807
- Recruiting
Clinical Site
McKinney, Texas, 75071
- Recruiting
Clinical Site
Miami, Florida, 33122
- Recruiting
Clinical Site
Miami, Florida, 33155
- Recruiting
Clinical Site
Miami, Florida, 33173
- Recruiting
Clinical Site
Miami, Florida, 33186
- Recruiting
Clinical Site
Miami Gardens, Florida, 33014
- Recruiting
Clinical Site
Miami Gardens, Florida, 33104
- Recruiting
Clinical Site
Murrieta, California, 92562
- Recruiting
Clinical Site
Naples, Florida, 34105
- Recruiting
Clinical Site
New York, New York, 10003
- Recruiting
Clinical Site
Orange, California, 92866
- Recruiting
Clinical Site
Orlando, Florida, 32807
- Recruiting
Clinical Site
Phoenix, Arizona, 85004
- Recruiting
Clinical Site
Port Royal, South Carolina, 29935
- Recruiting
Clinical Site
San Diego, California, 92123
- Recruiting
Clinical Site
Scottsdale, Arizona, 85253
- Recruiting
Clinical Site
Snellville, Georgia, 30078
- Recruiting
Clinical Site
Sugarland, Texas, 77478
- Recruiting
Clinical Site
Tampa, Florida, 33629
- Recruiting
Clinical Site
Tigard, Oregon, 97223
- Recruiting
Clinical Site
Tucson, Arizona, 85704
- Recruiting
Clinical Site
West Long Branch, New Jersey, 07764
- Recruiting
Clinical Site
West Palm Beach, Florida, 33407
Canada4 sites, 4 recruiting
- Not yet recruiting
Clinical Site
Brampton, Ontario, L6W 2Z8
- Recruiting
Clinical Site
Lévis, Quebec, G6V 0C9
- Recruiting
Clinical Site
London, Ontario, N6A 5W9
- Recruiting
Clinical Site
Toronto, Ontario, M4N 3M5
Argentina3 sites, 3 recruiting
- Recruiting
Clinical Site
Caba, Buenos Aires F.D., C1133AAH
- Recruiting
Clinical Site
Córdoba, Córdoba Province, X5009BIN
- Recruiting
Clinical Site
Córdoba, X5004AOA
Chile3 sites, 3 recruiting
- Recruiting
Clinical Site
Antofagasta, Antofagasta, 1240000
- Recruiting
Clinical Site
Santiago, 7500710
- Recruiting
Clinical Site
Santiago, 7560359
Bulgaria2 sites, 2 recruiting
- Recruiting
Clinical Site
Pernik, Pernik, 2304
- Recruiting
Clinical Site
Sofia, Sofia, 1408
Czechia2 sites, 2 recruiting
- Recruiting
Clinical Site
Choceň, 565 01
- Recruiting
Clinical Site
Prague, 150 00
Hungary2 sites, 2 recruiting
- Recruiting
Clinical Site
Pécs, 7623
- Recruiting
Clinical Site
Pécs, 7633
South Korea2 sites, 2 recruiting
- Recruiting
Clinical Site
Daegu, 41404
- Recruiting
Clinical Site
Incheon, 21565
Portugal1 site, 1 recruiting
- Recruiting
Clinical Site
Torres Vedras, Lisbon District, 2560-280
Slovakia1 site, 1 recruiting
- Recruiting
Clinical Site
Vranov nad Topľou, 093 01
About this study
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
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.
- Being tested
- ML-007C-MA, Placebo
- Keywords
- Alzheimer Disease, Brain Diseases, Central Nervous System Diseases, Delusions, Dementia, Hallucinations, Mental Disorders, Nervous System Diseases, Neurocognitive Disorders, Neurodegenerative Diseases, Psychotic Disorders, Schizophrenia Spectrum and Other Psychotic Disorders, Tauopathies, Muscarinic Antagonists, Muscarinic Agonists, Cholinergic Agents
- Medical subject headings
- Alzheimer Disease, Brain Diseases, Central Nervous System Diseases, Delusions, Dementia, Hallucinations, Mental Disorders, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ML-007C-MADrug
ML-007C-MA dosed as 105/1.5 mg BID, or 210/3 mg BID
PlaceboDrug
Placebo Tablets
| Study group | Role | What they receive |
|---|---|---|
| ML-007C-MA | Experimental | Not described Receives: Drug: ML-007C-MA |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score
NPI-C H+D scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.
Measured: Baseline and End of Treatment (7 weeks)
Secondary outcomes (2)
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) hallucinations and delusions domain-specific score
The CGI-S scale is a clinician-rated, 7-point scale that is designed to rate the severity of the participant's hallucinations and delusions using the investigator's judgment and past experience with participants who have Alzheimer's disease psychosis. Higher scores on this scale indicate worse outcomes.
Measured: Baseline and End of Treatment (7 weeks)
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory - Clinician Agitation and Aggression (NPI-C A+A) score in participants who have a CGI-S agitation/aggression domain-specific score of ≥4 at Baseline
NPI-C A+A scale includes 2 domains from the NPI-C scale, namely, agitation and aggression. These 2 domains include the following number of items to be rated by the clinician: Agitation, 13 items (maximum score = 39), and Aggression, 8 items (maximum score = 24). The maximum score for the NPI-C A+A scale is 63. Higher scores on this scale indicate more severe symptoms of agitation and aggression.
Measured: Baseline and End of Treatment (7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start15 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosis Associated With Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MapLight Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MapLight Therapeutics, Study director, MapLight Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887192
- Sponsor's protocol ID
- ML-007C-MA-221
- Other IDs
- 2024-519820-26-00
- Status last verified
- May 2026
- First submitted
- 14 Mar 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No