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Tests treatment safety and results for Psychosis Associated With Alzheimer's Disease
Official title A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
ClinicalTrials.gov ID: NCT06887192
What this study is testing
What is ML-007C-MA?
ML-007C-MA is an investigational medicine, being studied as a potential treatment for psychosis associated with alzheimer's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 90
You may be able to join if
- Willing and able to provide written informed consent, or, if deemed lacking in the capacity to provide informed consent, the following requirements...
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Anaheim, California, United States
- Orange, California, United States
- San Diego, California, United States
- Boca Raton, Florida, United States
- Deerfield Beach, Florida, United States
- Doral, Florida, United States
- Homestead, Florida, United States
- Miami, Florida, United States
- Miami Gardens, Florida, United States
- Naples, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Augusta, Georgia, United States
- Las Vegas, Nevada, United States
- West Long Branch, New Jersey, United States
- Dayton, Ohio, United States
+ 16 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Anaheim, California, United States; Orange, California, United States; San Diego, California, United States and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.