At a glance
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Apathy in Dementia Methylphenidate Trial (ADMET)
In Brief
A Phase 2 clinical trial evaluating Methylphenidate, placebo, and 1 other intervention for Apathy and Alzheimer's Disease. Completed, enrolled 60 participants across 3 sites in 2 countries.
Detailed Summary
The Apathy in Dementia Methylphenidate Trial (ADMET) is a masked, placebo-controlled trial that will examine the efficacy and safety of methylphenidate for the treatment of clinically significant apathy in patients with Alzheimer's dementia.
Study Details
Timeline
Interventions
The target dose is 20 mg per day provided as two 10 mg doses administered orally. Patients will start by taking 10 mg daily (two 5 mg over-encapsulated tablets) for three days, at which time the dose will be increased to 20 mg per day (four 5 mg over-encapsulated tablets). In the event of significant side-effects, the dose will be reduced to a minimum of 10 mg per day. The study drug will be administered for 6 weeks.
Patients will start with two capsules of placebo for three days, at which time the dose will be increased to four capsules. The dose may be reduced to a minimum of two capsules per day if there appears to be significant side-effects. Placebo will be administered for 6 weeks.
The psychosocial intervention will consist of three components: a counseling session, the provision of education materials, and 24-hour availability for crises. The counseling session, in which a trained study clinician will counsel the primary caregiver, lasts approximately 20-30 minutes, and consists of the following elements: * Review and adjustment of the patient and caregiver supportive care plans * Emotional support and opportunity to ventilate feelings * Counseling regarding specific caregiving skills * Assistance with problem solving of specific issues that the caregiver brings to the sessions * Answers for questions regarding the educational materials The educational materials will consist of a copy of the book The 36-Hour Day