Designing a trial to evaluate potential treatments for Apathy in Dementia: The apathy in dementia methylphenidate trial (ADMET)

Lea T. Drye, Roberta W. Scherer, Krista L. Lanctôt, Paul B. Rosenberg, Nathan Herrmann, David Bachman, Jacobo E. Mintzer

Research output: Contribution to journalArticle

Abstract

Background: Research on efficacious treatments for apathy in Alzheimer disease has been hindered by a lack of consensus diagnosis, difficulties in measurement, and studies with small sample sizes. Methods: In designing the Apathy in Dementia Methylphenidate Trial (ADMET), a trial to evaluate the efficacy and safety of methylphenidate for the treatment of apathy in Alzheimer disease, we encountered the following issues: defining and measuring apathy, distinguishing apathy and depression, determining an appropriate test treatment, selecting relevant secondary outcomes, recruiting participants, and deciding on a suitable method for treatment unmasking. ADMET is a 6-week randomized, double-masked, placebo-controlled multicenter clinical trial with two parallel treatment groups assigned in a 1:1 ratio with randomization stratified by clinical center. The recruitment goal is 60 randomized participants over 2 years. The primary outcomes are change in apathy severity as measured by the Apathy Evaluation Scale and the Alzheimer Disease Cooperative Study-Clinical Global Impression of Change. Conclusion: The design decisions made for ADMET are important elements to be considered in trials assessing the safety and efficacy of medications for clinically significant apathy in Alzheimer disease.

Original languageEnglish (US)
Pages (from-to)549-559
Number of pages11
JournalAmerican Journal of Geriatric Psychiatry
Volume21
Issue number6
DOIs
StatePublished - Jun 2013

Keywords

  • Alzheimer dementia
  • Apathy
  • Methylphenidate
  • Randomized trial

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Psychiatry and Mental health

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