Designing a trial to evaluate potential treatments for apathy in dementia: The Apathy in Dementia Methylphenidate Trial (ADMET): 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)
JournalAmerican Journal of Geriatric Psychiatry
DOIs
StateAccepted/In press - Apr 4 2012
Externally publishedYes

Fingerprint

Apathy
Methylphenidate
Dementia
Alzheimer Disease
Therapeutics
Safety
Controlled Clinical Trials
Random Allocation
Sample Size
Multicenter Studies
Placebos
Depression

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Psychiatry and Mental health

Cite this

Designing a trial to evaluate potential treatments for apathy in dementia : The Apathy in Dementia Methylphenidate Trial (ADMET): The Apathy in Dementia Methylphenidate Trial (ADMET). / Drye, Lea T.; Scherer, Roberta W.; Lanctôt, Krista L.; Rosenberg, Paul B.; Herrmann, Nathan; Bachman, David; Mintzer, Jacobo E.

In: American Journal of Geriatric Psychiatry, 04.04.2012.

Research output: Contribution to journalArticle

Drye, Lea T. ; Scherer, Roberta W. ; Lanctôt, Krista L. ; Rosenberg, Paul B. ; Herrmann, Nathan ; Bachman, David ; Mintzer, Jacobo E. / Designing a trial to evaluate potential treatments for apathy in dementia : The Apathy in Dementia Methylphenidate Trial (ADMET): The Apathy in Dementia Methylphenidate Trial (ADMET). In: American Journal of Geriatric Psychiatry. 2012.
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