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

Part of paid clinical trials in Doral, Florida.

Sponsor
MapLight Therapeutics
Study ID
NCT07459660
Phase
PHASE2
Status
Recruiting
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Conditions

  • Psychosis Associated With Alzheimer's Disease

Eligibility Criteria

Sex
ALL
Age
55 Years - 91 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

Study Details

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).

Key Dates

Start date
Mar 25, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
210 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ML-007C-MA

Primary Outcome Measure

To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD [ Time Frame: From initial dose through end of treatment (up to 52 weeks) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Clinical SiteDoralFlorida33122-
Clinical SiteMiamiFlorida33155-
Clinical SiteMiamiFlorida33173-

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