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Diseases

MapLight Therapeutics Initiates Phase 2 Study for Potential Alzheimer's Disease Psychosis Treatment

Strategic Insights

— 1 min read

MapLight Therapeutics has initiated a Phase 2 study to evaluate the efficacy, safety, and tolerability of ML-007C-MA, an investigational novel M 1 /M 4 agonist, as a potential treatment for Alzheimer's disease psychosis (ADP). The study, known as VISTA, is a randomized, double-blind, placebo-controlled trial that aims to enroll approximately 300 patients. The primary endpoint of the study is the change in the Neuropsychiatric Inventory - Clinician Rating Scale Hallucinations and Delusions (NPI-C H+D) score from baseline to Week 7. This Phase 2 study is a critical milestone in the development of ML-007C-MA, which has shown promising results as a therapeutic strategy for ADP in a Phase 1 development program that included 270 healthy volunteers.

Key Takeaways:

  • The Phase 2 VISTA study is a randomized, double-blind, placebo-controlled trial evaluating a twice-daily dose of ML-007C-MA for the treatment of hallucinations and delusions associated with ADP.
  • The primary endpoint of the study is the change in the NPI-C H+D score from baseline to Week 7.
  • The study is expected to enroll approximately 300 patients globally.
  • ML-007C-MA has shown a favorable safety and tolerability profile in healthy elderly volunteers in Phase 1.
  • The drug is designed to activate both M1 and M4 muscarinic receptors in the central nervous system to drive efficacy while synchronizing the pharmacokinetics of the agonist and antagonist components to mitigate peripheral cholinergic side effects.
  • Alzheimer's disease psychosis (ADP) is a serious and common neuropsychiatric complication of Alzheimer's disease, occurring in approximately 40% of individuals with AD at some point.

Statistics:

  • 270 healthy volunteers were included in the Phase 1 development program for ML-007C-MA.
  • The Phase 2 VISTA study is expected to enroll approximately 300 patients globally.
  • 40% of individuals with Alzheimer's disease will experience Alzheimer's disease psychosis (ADP) at some point throughout the course of their illness.

Sources:

  • MapLight Therapeutics, Inc. (NCT06887192)
  • MapLight Therapeutics, Inc. (source - ML-007C-MA FAQ on their website)

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