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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.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
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:
Aged 55 to 90 years, inclusive, at time of informed consent.
Meets clinical criteria for Possible AD or Probable AD.
Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.
Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.
Has a designated care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug.
Has a NPI-C H+D score of ≥ 6 AND meet at least 1 of the following criteria:
Has a (CGI)-S hallucinations and delusions domain-specific score ≥4
Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive.
Key Exclusion Criteria:
Primary purpose
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Interventional model
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300 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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