An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-91
SponsorMapLight Therapeutics
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant's LAR must provide written informed consent. AND
The participant will provide informed assent.
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.
Disqualifiers
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 participant's ability to comply with study procedures, would preclude obtaining voluntary consent/assent, and/or would substantially impair the evaluation of study assessments.
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.
Trial design
Design model
Single group
Treatments tested in this trial
ML-007C-MA
DrugML-007C-MA dosed as 105/1.5 mg BID or 210/3 mg BID
Treatment groups
210 Participants
are divided into 1 treatment groupGroup A: ML-007C-MAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From initial dose through end of treatment (up to 52 weeks)Sponsors and contacts
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Source ClinicalTrials.gov