Psychosis Associated With Alzheimer's Disease study: ML-007C-MA
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 oral medication being studied for hallucinations and delusions associated with Alzheimer’s disease psychosis.
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
- The study wants to see if ML‑007C‑MA can reduce hallucinations and delusions compared to a placebo, measured by a standard questionnaire.
- Who it's for
- It is looking for men and women aged 55 to 90 who have Alzheimer’s disease and experience hallucinations or delusions.
- What's involved
- Participants will receive either the drug or a placebo, and will have regular visits where doctors assess their symptoms and safety through questionnaires and tests.
- Time commitment
- The study lasts about 2 months, with several clinic visits for assessments and medication monitoring.
- 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
- 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.
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
- 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.
- 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 is enrolling
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Anaheim, California, United States
- Long Beach, California, United States
- Murrieta, California, United States
- Orange, California, United States
- Redlands, California, United States
- San Diego, California, United States
- Denver, Colorado, 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
+ 42 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Anaheim, California, United States; Long Beach, California, United States; Murrieta, California, United States and 56 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.