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An Open-Label Study of ML-007C-MA in Adults with Alzheimer’s Disease Psychosis
EU CTIS ID: 2025-521757-16-00
What this study is testing
To evaluate the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with ADP
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 for consent must be met: a. The participant’s LAR must provide written informed consent. AND b. The participant will provide written (if capable) informed assent.
- Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007-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 meets the following criteria: a. Study care partner is in contact with the participant frequently enough to accurately report on the participant’s symptoms and on participant’s compliance with taking the study drug, in the investigator’s opinion b. Study care partner is fluent in the local language in which the study assessments will be administered. c. Study care partner agrees to participate in study assessments, accompany the participant to each study visit, and provide written consent to participate in the study.
- Has sufficient verbal ability to satisfactorily comply with study procedures (corrective measures such as hearing aids and reading glasses are allowed, if necessary) and is willing and able to attend clinic visits. Participants who can attend clinic visits using a wheelchair or other ambulatory assistive device are permitted.
- 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.
You likely can't join if
- Requires treatment with protocol-defined prohibited medications (Table 3)
- 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 participant’s ability to comply with study procedures, would preclude obtaining voluntary consent/assent, and/or would substantially confound the interpretation of the outcome measures in the study.
- Currently 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 participant’s ability to comply with study procedures, and/or would substantially confound the interpretation of the outcome measures in the study in the opinion of the investigator. (Note: Immediate Rollover participants may enter this study before laboratory test values and central ECG reports from the Screening/Baseline Visit (ie, Visit 1E/EOT visit of the antecedent study) are received from the central lab and ECG vendors.)
- At an elevated risk of suicidal behavior based on 1) investigator judgment, 2) history of suicidal behavior during or since the antecedent study, or 3) GCAS clinician score of 3 or 4 at Screening/Baseline (Immediate Rollovers), or Screening or Baseline Visits (Delayed Rollovers).
- Positive pregnancy test at Screening/Baseline (Immediate Rollovers), or Screening or Baseline Visits (Delayed Rollovers), or is lactating.
- Allergy or other intolerance to ML-007 or their excipients.
See the full eligibility criteria
Who can join
- 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: a. The participant’s LAR must provide written informed consent. AND b. The participant will provide written (if capable) informed assent.
- Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007-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 meets the following criteria: a. Study care partner is in contact with the participant frequently enough to accurately report on the participant’s symptoms and on participant’s compliance with taking the study drug, in the investigator’s opinion b. Study care partner is fluent in the local language in which the study assessments will be administered. c. Study care partner agrees to participate in study assessments, accompany the participant to each study visit, and provide written consent to participate in the study.
- Has sufficient verbal ability to satisfactorily comply with study procedures (corrective measures such as hearing aids and reading glasses are allowed, if necessary) and is willing and able to attend clinic visits. Participants who can attend clinic visits using a wheelchair or other ambulatory assistive device are permitted.
- 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.
- Women of childbearing potential and men who are sexually active with women of childbearing potential must be willing to adhere to contraception requirements and ova/sperm donation restrictions (Section 13.2). Women must meet 1 of the following criteria to be considered not of childbearing potential: a. Postmenopausal (spontaneous amenorrhea for at least 12 months before dosing without alternative medical explanation) and confirmation by documented FSH levels ≥40 mIU/mL. b. Surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral salpingectomy at least 3 months before dosing).
What rules you out
- Requires treatment with protocol-defined prohibited medications (Table 3)
- 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 participant’s ability to comply with study procedures, would preclude obtaining voluntary consent/assent, and/or would substantially confound the interpretation of the outcome measures in the study.
- Currently 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 participant’s ability to comply with study procedures, and/or would substantially confound the interpretation of the outcome measures in the study in the opinion of the investigator. (Note: Immediate Rollover participants may enter this study before laboratory test values and central ECG reports from the Screening/Baseline Visit (ie, Visit 1E/EOT visit of the antecedent study) are received from the central lab and ECG vendors.)
- At an elevated risk of suicidal behavior based on 1) investigator judgment, 2) history of suicidal behavior during or since the antecedent study, or 3) GCAS clinician score of 3 or 4 at Screening/Baseline (Immediate Rollovers), or Screening or Baseline Visits (Delayed Rollovers).
- Positive pregnancy test at Screening/Baseline (Immediate Rollovers), or Screening or Baseline Visits (Delayed Rollovers), or is lactating.
- Allergy or other intolerance to ML-007 or their excipients.
- Participant or study care partner is an employee or a family member of an employee of MapLight Therapeutics, Inc. or the investigator/study center.
- Judged by the investigator or Sponsor to be inappropriate for the study, including participants who were insufficiently adherent to study drug or study drug procedures in the antecedent study.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Mexico
- Canada
- Chile
- Korea, Republic of
- Serbia
- Argentina
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 - 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Mexico; Canada; Chile; Korea, Republic of and 2 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 EU CTIS; the study team decides eligibility.