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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
210
ML-007C-MA dosed as 105/1.5 mg BID or 210/3 mg BID
Clinical Site
Doral, Florida, United States
RECRUITINGClinical Site
Miami, Florida, United States
RECRUITINGClinical Site
Miami, Florida, United States
RECRUITINGTo 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.
Time frame: From initial dose through end of treatment (up to 52 weeks)
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