A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis

Recruiting · NCT06887192 · Interventional (participants receive a specific treatment) · Lead sponsor: MapLight Therapeutics

View the official record on ClinicalTrials.gov →

Alzheimer's disease Schizophrenia

Interventions studied

ML-007C-MAPlacebo

What this trial is 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.

Who can take part

Age range

55 Years to 90 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

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:
The participant's LAR must provide written informed consent AND
The participant will provide informed assent.
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:
Moderate to severe delusions, defined as NPI-C Delusions domain score of ≥ 2 on at least 2 of the 8 items OR
Moderate to severe hallucinations, defined as NPI-C Hallucinations domain score of ≥ 2 on at least 2 of the 7 items.
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

Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
Psychotic symptoms that are primarily attributable to substance abuse or a medical, neurological or psychiatric condition other than Alzheimer's disease.
Evidence of a CNS disorder other than Alzheimer's disease that is the primary cause of, or a significant contributor to the participant's dementia.
Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria.
Has an elevated risk of suicidal behavior
Has had an amyloid PET brain scan or CSF Alzheimer's disease biomarker test in the past 3 years with results inconsistent with a diagnosis of AD.
Evidence of a clinically significant and/or unstable medical condition that, in the opinion of the investigator or medical monitor, could substantially impair cognition, compromise participant safety, interfere with the participant's ability to comply with study procedures or substantially impair the evaluation of efficacy or safety assessments.
Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma
Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine).
Has previously participated in any clinical study with ML-007 or ML-007C-MA.
Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients.
Received or may have received an investigational drug, biological product or device within 90 days before Baseline (or 6 months for investigational Alzheimer's disease-modifying therapies).

Where it is running

60 locations listed across 11 US states.

Clinical Site - Phoenix, Arizona, United States
Clinical Site - Phoenix, Arizona, United States
Clinical Site - Scottsdale, Arizona, United States
Clinical Site - Scottsdale, Arizona, United States
Clinical Site - Tucson, Arizona, United States
Clinical Site - Tucson, Arizona, United States
Clinical Site - Anaheim, California, United States
Clinical Site - Anaheim, California, United States
Clinical Site - Long Beach, California, United States
Clinical Site - Long Beach, California, United States
Clinical Site - Murrieta, California, United States
Clinical Site - Murrieta, California, United States
Clinical Site - Orange, California, United States
Clinical Site - Orange, California, United States
Clinical Site - San Diego, California, United States
Clinical Site - San Diego, California, United States
Clinical Site - Denver, Colorado, United States
Clinical Site - Denver, Colorado, United States
Clinical Site - Boca Raton, Florida, United States
Clinical Site - Boca Raton, Florida, United States
Clinical Site - Deerfield Beach, Florida, United States
Clinical Site - Deerfield Beach, Florida, United States
Clinical Site - Doral, Florida, United States
Clinical Site - Doral, Florida, United States
Clinical Site - Homestead, Florida, United States
Clinical Site - Homestead, Florida, United States
Clinical Site - Miami, Florida, United States
Clinical Site - Miami, Florida, United States
Clinical Site - Miami, Florida, United States
Clinical Site - Miami, Florida, United States
Clinical Site - Miami, Florida, United States
Clinical Site - Miami, Florida, United States
Clinical Site - Miami, Florida, United States
Clinical Site - Miami, Florida, United States
Clinical Site - Miami Gardens, Florida, United States
Clinical Site - Miami Gardens, Florida, United States
Clinical Site - Miami Gardens, Florida, United States
Clinical Site - Miami Gardens, Florida, United States
Clinical Site - Naples, Florida, United States
Clinical Site - Naples, Florida, United States
Clinical Site - Orlando, Florida, United States
Clinical Site - Orlando, Florida, United States
Clinical Site - Tampa, Florida, United States
Clinical Site - Tampa, Florida, United States
Clinical Site - West Palm Beach, Florida, United States
Clinical Site - West Palm Beach, Florida, United States
Clinical Site - Augusta, Georgia, United States
Clinical Site - Augusta, Georgia, United States
Clinical Site - Snellville, Georgia, United States
Clinical Site - Snellville, Georgia, United States
Clinical Site - Las Vegas, Nevada, United States
Clinical Site - Las Vegas, Nevada, United States
Clinical Site - West Long Branch, New Jersey, United States
Clinical Site - West Long Branch, New Jersey, United States
Clinical Site - Dayton, Ohio, United States
Clinical Site - Dayton, Ohio, United States
Clinical Site - Independence, Ohio, United States
Clinical Site - Independence, Ohio, United States
Clinical Site - Tigard, Oregon, United States
Clinical Site - Tigard, Oregon, United States

Showing 60 of 110 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →