Psychosis Associated With Alzheimer's Disease
Conditions
Keywords
Alzheimer Disease, Brain Diseases, Central Nervous System Diseases, Delusions, Dementia, Hallucinations, Mental Disorders, Nervous System Diseases, Neurocognitive Disorders, Neurodegenerative Diseases, Psychotic Disorders, Schizophrenia Spectrum and Other Psychotic Disorders, Tauopathies, Muscarinic Antagonists, Muscarinic Agonists, Cholinergic Agents
Brief summary
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).
Interventions
DRUGML-007C-MA
ML-007C-MA dosed as 105/1.5 mg BID or 210/3 mg BID
Sponsors
MapLight Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 91 Years
Healthy volunteers
No
Inclusion criteria
1. 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: 1. The participant's LAR must provide written informed consent. AND 2. The participant will provide informed assent. 2. Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007C-MA-221). 3. May benefit from long-term therapy with open-label ML-007C-MA treatment, in the judgment of the investigator. 4. 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. 5. 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
1. Under the care of hospice, bed-bound, or receiving end-of-life palliative care. 2. Requires treatment with protocol-defined prohibited medications. 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 impair the evaluation of study assessments. 4. 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 confound the interpretation of the outcome measures in the study in the opinion of the investigator. 5. Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients since the antecedent study. 6. Has an elevated risk of suicidal behavior.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD | From initial dose through end of treatment (up to 52 weeks) | using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation. |
Countries
Bulgaria, France, United States
Contacts
STUDY_DIRECTORMapLight Therapeutics
MapLight Therapeutics
Outcome results
None listed