Phase 2 Schizophrenia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The person joining the trial must be willing and able to give written consent, or — if they are not able to do so — a legal representative must give written consent on their behalf, and the person themselves must also give their assent.
• The person must have a diagnosis that meets the clinical criteria for Possible or Probable Alzheimer's disease.
• The person must have been experiencing psychotic symptoms (such as hallucinations or delusions) for at least 2 months before the screening visit, meeting specific international criteria for these symptoms.
• The person must have been living in the same home, assisted living residence, or nursing home for at least 6 weeks before the screening visit.
• The person must have a designated care partner who is in regular enough contact to accurately report on their symptoms and whether they are taking the study medication.
• The person must score at least 6 on a specific psychosis symptom scale (NPI-C H+D), and also show moderate to severe delusions on at least 2 of 8 assessed areas, or moderate to severe hallucinations on at least 2 of 7 assessed areas (confirm with trial site).
• The person must score 4 or higher on a clinician-rated scale measuring the severity of hallucinations and delusions (CGI-S) (confirm with trial site).
• The person must score between 6 and 26 (inclusive) on the Mini-Mental State Examination, a standard test of cognitive function.

Who may not be able to join:

• People who are under hospice care, are bed-bound, or are receiving end-of-life palliative care.
• People whose psychotic symptoms are mainly caused by substance use or by a medical, neurological, or psychiatric condition other than Alzheimer's disease.
• People who have another brain or nervous system disorder that is the main cause of, or a major contributor to, their dementia.
• People who have had a moderate or severe major depressive episode within 3 months of the screening visit, based on standard diagnostic criteria.
• People who are considered to have an elevated risk of suicidal behaviour.
• People who have had a brain amyloid PET scan or a spinal fluid Alzheimer's disease biomarker test within the past 3 years that showed results inconsistent with an Alzheimer's disease diagnosis.
• People who have a significant and/or unstable medical condition that, in the opinion of the investigator, could meaningfully affect thinking, safety, ability to follow study procedures, or the accuracy of the trial's assessments.
• People who have gastric retention (the stomach emptying too slowly), urinary retention (inability to fully empty the bladder), or a specific type of glaucoma called narrow-angle (angle-closure) glaucoma.
• People who have met the criteria for an alcohol or substance use disorder (not including caffeine or nicotine) within the past 12 months.
• People who have previously taken part in any clinical study involving the study drug ML-007 or ML-007C-MA.
• People who have developed an allergy or intolerance to the study drug ML-007C-MA or any of its ingredients.
• People who have received, or may have received, an experimental drug, biological product, or medical device within the 90 days before the baseline visit, or within 6 months if the experimental treatment was an Alzheimer's disease-modifying therapy.

Important: Always verify eligibility with the trial site directly before applying.