Apathy in Dementia Methylphenidate Trial (ADMET)
- Conditions
- ApathyAlzheimer's Disease
- Interventions
- Registration Number
- NCT01117181
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Brief 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.
- Detailed Description
The Apathy in Dementia Methylphenidate Trial (ADMET), funded by the National Institute of Aging, is a Phase II, placebo-controlled, masked, 3-center randomized clinical trial. ADMET will enroll 60 patients with Alzheimer's disease (AD) and significant apathy from outpatient, nursing home, and assisted living facilities along with their primary caregiver. Eligible and willing patients will be randomly assigned to methylphenidate (20 mg per day) or placebo. At baseline and each in-person follow-up visit, all caregivers and patients will be provided with a standardized psychosocial intervention consisting of a counseling session, provision of educational materials, and 24-hour availability for crises. Efficacy and safety outcomes will be measured at baseline and at in-person follow-up visits at 2, 4, and 6 weeks following randomization. Telephone contact will take place at 1, 3, and 5 weeks after randomization.
ADMET has 80% power to detect a difference of at least 3.3 in change in the Apathy Evaluation Scale scores between the two treatment groups. It also has 80% power to detect an absolute difference of 35% or more in the change in the proportion of study participants improving on te Clinical Global Impression of Change, given that 20% to 305 of participants in the placebo group show improvement.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methylphenidate Psychosocial intervention Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention Placebo placebo matching placebo and psychosocial intervention Placebo Psychosocial intervention matching placebo and psychosocial intervention Methylphenidate Methylphenidate Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
- Primary Outcome Measures
Name Time Method Apathy Evaluation Scale (AES) baseline to 6 weeks Change in score of Apathy Evaluation Scale from baseline to 6 weeks; the minimum score is 18; the maximum score is 72. Higher scores indicate more severe apathy.
Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change baseline to 6 weeks Proportion of individuals improving on Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) from baseline to 6 weeks; the CGIC is a 7-point Likert scale used to rate each patient with the following scores: "marked worsening"(7), "moderate worsening" (6), "minimal worsening"(5), "no change"(4), "minimal improvement"(3), "moderate improvement"(2), "marked improvement"(1). Ratings were based on an interview with the caregiver and an examination of the patient. The CGIC requires the clinician to consider a number of aspects of apathy, such as level of initiative, level of interest, and emotional engagement.
- Secondary Outcome Measures
Name Time Method Digit Span baseline and 6 weeks Change in Digit Span from baseline to 6 weeks. The Wechsler Adult Intelligence Scale - Revised Digit Span is used to assess auditory attention and working memory. Both forward and backward span is assessed. Both tests consist of six number sequences that the psychometrist reads aloud one at a time. After each sequence is read, the participant must repeat the digits back in the same (forward) or reverse (backward) order. Scores range from 0 to 16, with higher numbers indicate better functioning.
Mini-Mental State Exam (MMSE) baseline and 6 weeks Change in Mini-Mental State Exam score from baseline to 6 weeks; this cognitive test estimates of dementia severity. Domains included orientation, memory, working memory, naming, following verbal and written commands, spontaneously writing a sentence, and copying two overlapping pentagons. The minimum MMSE score is 0; the maximum MMSE score is 30. Lower MMSE scores indicate more severe cognitive impairment.
Neuropsychiatric Inventory (NPI): Apathy Subscale baseline to week 6 Change from baseline to 6 weeks in neuropsychiatric symptoms in apathy subscore. Frequency (ranges from 1=occasionally, less than once/week to 4 = very frequently, once or more/day or continuously) and severity (1=mild, 2=moderate, 3=severe) scales are scored based on responses from an informed caregiver involved in the patient's life. To obtain the NPI score, the severity score is multiplied by the frequency score. Range is 0 to 12. Larger numbers indicate more severe behavioral disturbance.
Vital Status vital status at 6 weeks vital status as measured by death
Electrolytes 6 weeks Percent of participants with abnormal electrolyte values at 6 weeks as assessed by local laboratory
Electrocardiogram (ECG) 6 weeks Abnormal electrocardiogram results at 6 weeks
Trial Locations
- Locations (3)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada