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ML-007C-MA

Phase 2

Psychosis Associated With Alzheimer's Disease | Small molecule | Neurology |MapLight Therapeutics, Inc.|Last Updated: May 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment510
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07459660An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease PsychosisPHASE2 RECRUITING 210 — — Mar 25, 2026Mar 1, 2029Apr 14, 20263 United States
NCT06887192A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease PsychosisPHASE2 RECRUITING 300 — — Aug 15, 2025Dec 1, 2027May 19, 202640 United States, Argentina +6
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD
From initial dose through end of treatment (up to 52 weeks)

using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.

Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score
Baseline and End of Treatment (7 weeks)

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.

Secondary Endpoints
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) hallucinations and delusions domain-specific score
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
Baseline and End of Treatment (7 weeks)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ML-007C-MAEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ML-007C-MADRUGML-007C-MA dosed as 105/1.5 mg BID or 210/3 mg BID
PlaceboDRUGPlacebo Tablets
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Eligibility Criteria
Age Range55 Years — 91 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria 1. 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: 1. The participant's LAR must provide written informed consent. AND 2. The participant will provi...

Countries:United StatesArgentinaBulgariaCanadaCzechiaFranceRomaniaSouth Korea
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06887192primaryCompletionDate: changed
LOWMay 26, 2026NCT07459660Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT06887192studyFirstPostDate: changed
LOWMay 24, 2026NCT07459660studyFirstPostDate: changed