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Am J Geriatr Psychiatry. 2013 Jun;21(6):549-59. doi: 10.1016/j.jagp.2012.12.018. Epub 2013 Jan 18.

Designing a trial to evaluate potential treatments for apathy in dementia: the apathy in dementia methylphenidate trial (ADMET).

Author information

1
Johns Hopkins Bloomberg School of Public Health. Electronic address: ldrye@jhsph.edu.

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.

PMID:
23567407
PMCID:
PMC3402588
DOI:
10.1097/JGP.0b013e31824afba8
[Indexed for MEDLINE]
Free PMC Article

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