A study to assess the efficacy and safety of ML-007C-MA for the treatment of Alzheimer's disease psychosis
Information about the drug that will be tested in the study
Administration
Oral administration (tablet) twice a day, within approximately 1 hour after consuming food
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
Participants will be selected by chance to receive one of the following options:
- An oral administration of ML-007C-MA
- An oral administration of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).
Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the efficacy and safety of ML-007C-MA in people aged 55 to 90 years with hallucinations and delusions associated with Alzheimer's disease psychosis.
How long will the treatment last?
- 7 weeks
What your involvement will entail?
- During the study, participants will be asked to complete tests that will assess their cognitive function, agitation, hallucinations and delusions
- Undergo brain scan (PET) or CSF examination (lumbar puncture).
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be between 55 and 90 years old
- Meets clinical criteria for possible or probable Alzheimer’s disease
- Have psychotic symptoms
- Reside at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before screening
- Have a study partner who has a sufficient contact with the participant and is willing to participate in study procedures throughout the study duration.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- 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
- Moderate or severe major depressive episode within the past 3 months
- Alcohol or substance abuse
- Has previously participated in any clinical study with ML-007 or ML-007C-MA.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
EuCT Number
2024-519820-26-00
Clinicaltrials.gov identifier
NCT06887192
Study contact information
Link to full text
https://clinicaltrials.gov/study/NCT06887192
https://euclinicaltrials.eu/ctis-public/view/2024-519820-26-00
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) in April 2026.
