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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well ML-007C-MA works and how safe it is compared with a placebo, a treatment with no active drug. It is for adults ages 55 to 90 with Alzheimer's disease who have hallucinations (seeing or hearing things that are not there) and delusions (believing things that are not true).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Give written consent to join. If you cannot give consent, a legally authorized person must give written consent, and you must agree to join.
  • Have a diagnosis of possible or probable Alzheimer's disease.
  • Have hallucinations or delusions that meet the study's rules for at least 2 months before screening.
  • Have lived in the same home, assisted living center, or nursing home for at least 6 weeks before screening.
  • Have a care partner with enough contact to report your symptoms and whether you take the study drug.
  • Have a combined hallucination and delusion score of at least 6 on the NPI-C symptom scale. At least 2 hallucination items or 2 delusion items must score 2 or higher.
  • Have a score of at least 4 on the CGI-S scale for how severe hallucinations and delusions are.
  • Score 6 to 26 on the MMSE, a test of memory and thinking.

Who can't join

  • Are in hospice, cannot get out of bed, or receive comfort care at the end of life.
  • Have hallucinations or delusions mainly caused by substance misuse or a condition other than Alzheimer's. Also excluded: another brain or nervous system disorder that is a main cause or major contributor to dementia.
  • Had a moderate or severe episode of major depression within 3 months before screening, or have a raised risk of suicidal behavior.
  • Had a brain scan for amyloid or a spinal fluid test for Alzheimer's within the past 3 years with results that do not support an Alzheimer's diagnosis.
  • Have a serious or unstable medical condition that could greatly affect thinking, safety, following study steps, or study results. Also excluded: trouble emptying the stomach or bladder, or narrow-angle glaucoma, a type of eye disease.
  • Had an alcohol or substance use disorder within the past 12 months, not counting caffeine or nicotine.
  • Previously joined a study of ML-007 or ML-007C-MA, or have an allergy or cannot tolerate ML-007C-MA or any of its ingredients.
  • Received or may have received an experimental drug, biological treatment, or device within 90 days before the starting visit. For experimental treatments meant to change the course of Alzheimer's, the limit is 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 nursing home facility for a minimum of 6 weeks before Screening. 5. 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. 6. Has a NPI-C H+D score of ≥ 6 AND meet at least 1 of the following criteria: 1. Moderate to severe delusions, defined as NPI-C Delusions domain score of ≥ 2 on at least 2 of the 8 items OR 2. Moderate to severe hallucinations, defined as NPI-C Hallucinations domain score of ≥ 2 on at least 2 of the 7 items. 7. Has a (CGI)-S hallucinations and delusions domain-specific score ≥4 8. Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive. Key Exclusion Criteria: 1. Under the care of hospice, bed-bound, or receiving end-of-life palliative care. 2. Psychotic symptoms that are primarily attributable to substance abuse or a medical, neurological or psychiatric condition other than Alzheimer's disease. 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. Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria. 5. Has an elevated risk of suicidal behavior 6. 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. 7. 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. 8. Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma 9. Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine). 10. Has previously participated in any clinical study with ML-007 or ML-007C-MA. 11. Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients. 12. 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).

Study sites (37)

AZ

CA

CO

FL

GA

LA

NJ

NV

NY

OH

OR

SC

TX

WA