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NCT06887192 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
A Phase 2 study of Psychosis Associated With Alzheimer's Disease, sponsored by MapLight Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT06887192: Recruiting Phase 2 study of Psychosis Associated With Alzheimer's Disease, sponsored by MapLight Therapeutics.
NCT06887192 is a Phase 2 study of Psychosis Associated With Alzheimer's Disease that is actively recruiting participants, run by MapLight Therapeutics. The registered enrollment target is 300 participants, below the 488-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06887192, a Phase 2 study of Psychosis Associated With Alzheimer's Disease, is actively recruiting participants, sponsored by MapLight Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study 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). 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ML-007C-MA
Study Locations (20)
Florida
- Clinical Site - Boca Raton
- Clinical Site - Deerfield Beach
- Clinical Site - Doral
- Clinical Site - Homestead
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami Gardens
- Clinical Site - Miami Gardens
- Clinical Site - Naples
- Clinical Site - Orlando
- Clinical Site - West Palm Beach
Arizona
- Clinical Site - Phoenix
- Clinical Site - Scottsdale
- Clinical Site - Tucson
California
- Clinical Site - Anaheim
- Clinical Site - Orange
- Clinical Site - San Diego
Nevada
- Clinical Site - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-08-15 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT06887192 shows while recruiting
NCT06887192 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 488-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Psychosis Associated With Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06887192 names 20 study sites across 4 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT06887192 about?
NCT06887192 is a clinical study titled "A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of 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 ev...
What is the current status of trial NCT06887192?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2025-08-15. Estimated completion is 2027-12.
What conditions does trial NCT06887192 study?
This clinical trial studies the following conditions: Psychosis Associated With Alzheimer's Disease.
What interventions are being tested in trial NCT06887192?
The interventions under investigation include: Placebo (DRUG), ML-007C-MA (DRUG).
Who is sponsoring clinical trial NCT06887192?
This trial is sponsored by MapLight Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06887192 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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