At a glance
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Apathy in Dementia Methylphenidate Trial 2
In Brief
A Phase 3 clinical trial evaluating Methylphenidate and Placebo for Apathy and Alzheimer's Disease. Completed, enrolled 200 participants across 10 sites in 2 countries.
Detailed Summary
Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a Phase III, placebo-controlled, masked, 6 month, multi-center randomized clinical trial sponsored by National Institutes of Aging involving 200 participants with Alzheimer's disease (AD). ADMET 2 is designed to examine the efficacy and safety of methylphenidate as treatment for clinically significant apathy in AD participants. ADMET 2 will enroll participants from real world settings such as outpatient, nursing home, and assisted living facilities and will examine the effects of methylphenidate on apathy and cognition. ADMET 2 will also conduct careful safety monitoring.
Study Details
Timeline
Interventions
Two 5mg methylphenidate over-encapsulated drug taken twice a day for 6 months (total of 20 mg methylphenidate per day), and psychosocial intervention
Two over-encapsulated placebo taken twice a day for 6 months and psychosocial intervention