RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-15
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06887192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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:
  2. 1. The participant's LAR (or care partner, if local regulations allow) must provide written informed consent AND
  3. 2. The participant will provide written (if capable) informed assent.
  4. 2. Aged 55 to 90 years, inclusive, at time of informed consent.
  5. 3. Meets clinical criteria for Possible AD or Probable AD.
  6. 4. Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.
  7. 5. Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.
  8. 6. 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.
  9. 7. Has a NPI-C H+D score of ≥ 6 AND meet at least 1 of the following criteria:
  10. 1. Moderate to severe delusions, defined as NPI-C Delusions domain score of ≥ 2 on at least 2 of the 8 items OR
  11. 2. Moderate to severe hallucinations, defined as NPI-C Hallucinations domain score of ≥ 2 on at least 2 of the 7 items.
  12. 8. Has a (CGI)-S hallucinations and delusions domain-specific score ≥4
  13. 9. Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive.
  1. 1. Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
  2. 2. Psychotic symptoms that are primarily attributable to substance abuse or a medical, neurological or psychiatric condition other than Alzheimer's disease.
  3. 3. 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.
  4. 4. Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria.
  5. 5. Has had an amyloid positron emission tomography (PET) brain scan or cerebrospinal fluid (CSF) Alzheimer's disease biomarker test in the past 3 years with results inconsistent with a diagnosis of AD.
  6. 6. 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.
  7. 7. Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma
  8. 8. Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine).
  9. 9. Has previously participated in any clinical study with ML-007 or ML-007C-MA.
  10. 10. 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).

Contacts and Locations

Study Contact

Clinical Trials Contact Center
CONTACT
+1 650 839 4380
ML-007C-MA-ADP@maplightrx.com

Principal Investigator

MapLight Therapeutics
STUDY_DIRECTOR
MapLight Therapeutics

Study Locations (Sites)

Clinical Site
Orange, California, 92866
United States
Clinical Site
Boca Raton, Florida, 33428
United States
Clinical Site
Miami, Florida, 33155
United States
Clinical Site
Miami, Florida, 33173
United States
Clinical Site
Miami, Florida, 33186
United States
Clinical Site
Miami Gardens, Florida, 33014
United States
Clinical Site
Miami Gardens, Florida, 33104
United States
Clinical Site
Naples, Florida, 34105
United States
Clinical Site
West Palm Beach, Florida, 33407
United States

Collaborators and Investigators

Sponsor: MapLight Therapeutics

  • MapLight Therapeutics, STUDY_DIRECTOR, MapLight Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-15
Study Completion Date2027-02

Study Record Updates

Study Start Date2025-08-15
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • Alzheimer Disease
  • Brain Diseases
  • Central Nervous System Diseases
  • Delusions
  • Dementia
  • Hallucinations
  • Mental Disorders
  • Nervous System Diseases
  • Neurocognitive Disorders
  • Neurodegenerative Diseases
  • Psychotic Disorders
  • Schizophrenia Spectrum and Other Psychotic Disorders
  • Tauopathies

Additional Relevant MeSH Terms

  • Psychosis Associated With Alzheimer's Disease