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The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial
Roberta W Scherer1, Lea Drye2, Jacobo Mintzer3
1Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA. rschere1@jhu.edu.
Trials
|January 20, 2018
Summary
This study investigates methylphenidate for Alzheimer's disease apathy. Results from the ADMET 2 trial will determine if this medication effectively treats motivation loss in AD patients.
Area of Science:
- Neurology
- Psychiatry
- Clinical Trials
Background:
- Alzheimer's disease (AD) frequently presents with neuropsychiatric symptoms, notably apathy, impacting quality of life.
- Apathy, a common symptom in AD, significantly burdens patients and caregivers.
- Current treatment options for apathy in AD are limited.
Purpose of the Study:
- To evaluate the efficacy of methylphenidate in treating apathy in patients with Alzheimer's disease.
- To confirm or refute findings from the original Apathy in Dementia Methylphenidate Trial (ADMET).
Main Methods:
- The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a phase III, multi-center, randomized clinical trial.
- 200 participants with AD and apathy were randomized to receive either 20 mg of methylphenidate daily or a placebo for 6 months.
- Primary outcomes included changes in apathy scores and global clinical impression ratings, with secondary outcomes assessing cognition, safety, and cost-effectiveness.
Main Results:
- The ADMET 2 trial is designed to provide statistically significant data on methylphenidate's efficacy.
- The study aims to determine the impact of methylphenidate on apathy, cognition, and safety in AD patients.
Conclusions:
- Apathy is a prevalent and impactful symptom in Alzheimer's disease.
- Methylphenidate shows promise as a treatment for apathy in AD, warranting further investigation in larger trials like ADMET 2.
- ADMET 2 is expected to yield definitive results regarding methylphenidate's effectiveness for apathy in AD.
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