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A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Trial sites expanded: 55 → 62 locations
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Trial sites expanded: 52 → 55 locationsv13
  3. Trial sites expanded: 40 → 52 locationsv12
  4. Trial sites expanded: 26 → 40 locationsv11
  5. Primary and study completion dates: Feb 2027 to Dec 2027
    • Study sites: 24 to 26
    • Eligibility criteria shortened, about 4 words
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 22 to 24v9
  2. Study sites: 20 to 22v8
  3. Study sites: 16 to 20v7
  4. Study sites: 13 to 16v6
  5. Study sites: 2 to 13
    • Start date changed from estimate of Jul 2025 to Aug 15, 2025
    v5
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 2025 to Jul 2025
    • Site details revised at 2 of 2 sites
    v4
  7. Start date: Mar 2025 to Jun 2025v3
  8. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06887192
Lead Sponsor MapLight Therapeutics
Conditions
(from sponsor)		 Psychosis Associated With Alzheimer's Disease
Related terms 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
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov