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New treatment option for Psychosis Associated With Alzheimer's Disease
Official title An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis
ClinicalTrials.gov ID: NCT07459660
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-222 is a 52-week, flexible-dose, open-label extension study designed to evaluate the long-term safety, tolerability, and effectiveness of ML007C-MA in participants with ADP who have completed the antecedent study (ie, Study ML-007C-MA-221).
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
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 91
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.
- Has completed the blinded Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007C-MA-221).
- May benefit from long-term therapy with open-label ML-007C-MA treatment, in the judgment of the investigator.
You likely can't join if
- Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
- Requires treatment with protocol-defined prohibited medications.
- Has developed a new or worsening medical comorbidity during or since the antecedent study that, in the opinion of the investigator and/or medical...
- Has or had a clinically significant abnormal physical examination, vital sign, ECG or clinical laboratory safety result during or since the...
- Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients since the antecedent study.
- Has an elevated risk of suicidal behavior.
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.
- Has completed the blinded Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007C-MA-221).
- May benefit from long-term therapy with open-label ML-007C-MA treatment, in the judgment of the investigator.
- Has a designated study care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug.
- Resides in a stable living environment (eg, home, residential assisted living, or nursing home facility) and is expected to remain in the living situation throughout the study.
- Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
- Requires treatment with protocol-defined prohibited medications.
- Has developed a new or worsening medical comorbidity during or since the antecedent study that, in the opinion of the investigator and/or medical monitor, would compromise participant safety, interfere with the...
- Has or had a clinically significant abnormal physical examination, vital sign, ECG or clinical laboratory safety result during or since the antecedent study that would compromise participant safety, interfere with the...
- Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients since the antecedent study.
- Has an elevated risk of suicidal behavior.
The study team makes the final eligibility decision.
Where it's taking place
- Doral, Florida, United States
- Miami, Florida, United States
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 91 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Doral, Florida, United States; Miami, Florida, United States. 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.