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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521757-16-00 | EU Trial (CTIS) Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ML-007C-MA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ML-007C-MA | Drug | ML-007C-MA dosed as 105/1.5 mg BID or 210/3 mg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD | using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation. | From initial dose through end of treatment (up to 52 weeks) |
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Inclusion 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:
Has completed the Double-Blind 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.
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Contact Center | Contact | +1 650 839 4380 | ML-007C-MA-ADP@maplightrx.com |
| Name | Affiliation | Role |
|---|---|---|
| MapLight Therapeutics | MapLight Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Recruiting | Doral | Florida | 33122 | United States | |
| Clinical Site |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D003702 | Delusions |
| D003704 | Dementia |
| D006212 | Hallucinations |
| D001523 | Mental Disorders |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D019636 | Neurodegenerative Diseases |
| D011618 | Psychotic Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D024801 | Tauopathies |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| Recruiting |
| Miami |
| Florida |
| 33155 |
| United States |
| Clinical Site | Recruiting | Miami | Florida | 33173 | United States |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |