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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Hallucinations and Delusions Associated with Alzheimer's Disease Psychosis

What is this Study about?

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.

What Will Happen in This Study?

Participant will take the study drug or placebo orally.
Planned duration of treatment is 7 weeks.

Who is Eligible to Participate in this Study?

Male or female participants aged 55 to 90 years of age
Must have a study partner
Presence of psychotic symptoms for at least 2 months before Screening.

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Clinical Trial

Target Population

Person at risk of Alzheimer's disease (AD) or living with pre-clinical AD

Study Location

In-Person
Ontario

Recruitment End Date

February 1, 2027
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