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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
MapLight Therapeutics
Study ID
NCT06887192
Phase
PHASE2
Status
Recruiting
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Conditions

  • Psychosis Associated With Alzheimer's Disease

Eligibility Criteria

Sex
ALL
Age
55 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • ML-007C-MA — DRUG
    ML-007C-MA dosed as 105/1.5 mg BID, or 210/3 mg BID
  • Placebo — DRUG
    Placebo Tablets

Study Details

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.

Key Dates

Start date
Aug 15, 2025
Status verified
May 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ML-007C-MA
  • Placebo Comparator: Placebo

Primary Outcome Measure

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

Central Contacts

Locations (27)

FacilityCityStateZIPSite coordinators
Clinical SitePhoenixArizona85004-
Clinical SiteScottsdaleArizona85253-
Clinical SiteTucsonArizona85704-
Clinical SiteAnaheimCalifornia92805-
Clinical SiteOrangeCalifornia92866-
Clinical SiteSan DiegoCalifornia92123-
Clinical SiteBoca RatonFlorida33428-
Clinical SiteDeerfield BeachFlorida33442-
Clinical SiteDoralFlorida33122-
Clinical SiteHomesteadFlorida33033-
Clinical SiteMiamiFlorida33122-
Clinical SiteMiamiFlorida33155-
Clinical SiteMiamiFlorida33173-
Clinical SiteMiamiFlorida33186-
Clinical SiteMiami GardensFlorida33014-
Clinical SiteMiami GardensFlorida33104-
Clinical SiteNaplesFlorida34105-
Clinical SiteOrlandoFlorida32807-
Clinical SiteTampaFlorida33629-
Clinical SiteWest Palm BeachFlorida33407-
Clinical SiteAugustaGeorgia30912-
Clinical SiteLas VegasNevada89121-
Clinical SiteWest Long BranchNew Jersey07764-
Clinical SiteDaytonOhio45459-
Clinical SiteIndependenceOhio44131-
Clinical SiteSugarlandTexas77478-
Clinical SiteBellevueWashington98007-

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