ML-007C-MA / Psychosis Associated With Alzheimer's Disease · Phase 2 Trial

An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2, open-label extension study registration designed to evaluate long-term safety, tolerability, and effectiveness of ML-007C-MA in adults with Alzheimer's disease psychosis. No results have been posted in this registry record; the study is currently enrolling by invitation and is planned to run for up to 52 weeks.

What was studied

Phase 2, Interventional, Single Group, Open label, Treatment purpose. Psychosis Associated With Alzheimer's Disease; age from 55 Years; to 91 Years. Intervention: ML-007C-MA. n = 210. 8 sites: United States, Bulgaria, France.

Key findings

Safety

This is a registry record with no results posted; efficacy and safety outcomes are not yet available. Open-label design without concurrent control group limits interpretability of safety and effectiveness findings.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record describing an ongoing Phase 2 open-label extension study with no results posted; no efficacy or safety data are yet available to evaluate.

Study design

As stated by the source record.

MethodsPrimary outcome measure: To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD (assessed at From initial dose through end of treatment (up to 52 weeks))

DesignPhase 2, Interventional, Single Group, Open label, Treatment purpose

PopulationPsychosis Associated With Alzheimer's Disease; age from 55 Years; to 91 Years

Sample size210

InterventionML-007C-MA

Setting8 sites: United States, Bulgaria, France

Reported figures

Quoted from the source exactly as published.

Planned enrollment210

Study phasePhase 2

Study duration52 weeks

Primary outcome measureSafety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with Alzheimer's disease

Caveats

This is a registry record with no results posted; efficacy and safety outcomes are not yet available.
Open-label design without concurrent control group limits interpretability of safety and effectiveness findings.
Study is an extension trial of a prior Phase 2 study; baseline characteristics and prior treatment response data are not provided in this record.
Recruitment status is by invitation only, which may affect generalizability.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Open-label design without control arm limits ability to assess efficacy.

Directness

moderate

Study directly targets Alzheimer's disease psychosis; focuses on safety and tolerability.

Consistency

insufficient

Registry record only; no results reported for consistency assessment.

Risk of bias

limited

Open-label design and lack of control group introduce bias risk.

Sample adequacy

moderate

Estimated 210 participants planned; adequate for safety evaluation in Phase 2.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07459660). This is a study registration, not published results. Lead sponsor: MapLight Therapeutics. Recruitment status: ENROLLING_BY_INVITATION. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 210 participants (ESTIMATED). Conditions: Psychosis Associated With Alzheimer's Disease. Interventions: DRUG: ML-007C-MA. Primary outcome measures: 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). Brief summary: ML-007C-MA-222 is a 52-week, flexible-dose, open-label extension study designed to evaluate the long-term safety, tolerability, and effectiveness of ML007C-MA in participants with ADP who have completed the antecedent study (ie, Study ML-007C-MA-221).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ML-007C-MANCT07459660Psychosis Associated With Alzheimer's DiseaseMapLight Therapeutics