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
MapLight Therapeutics
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.
Eligibility
- Age range
- 55–90 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Willing and able to provide written informed consent, or, if deemed lacking in the capacity to provide informed consent, the following requirements for consent must be met: 1. The participant's LAR must provide written informed consent AND 2. The participant will provide informed assent. 2. Meets clinical criteria for Possible AD or Probable AD. 3. Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening. 4. Has resided at the same home, residential assisted living, or n…
Interventions
- DrugML-007C-MA
ML-007C-MA dosed as 105/1.5 mg BID, or 210/3 mg BID
- DrugPlacebo
Placebo Tablets
Locations (26)
- Clinical SitePhoenix, Arizona
- Clinical SiteScottsdale, Arizona
- Clinical SiteTucson, Arizona
- Clinical SiteAnaheim, California
- Clinical SiteOrange, California
- Clinical SiteSan Diego, California