Safety and Efficacy of Methylphenidate for Apathy in Alzheimer’s Disease: A Randomized, Placebo-Controlled Trial
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OBJECTIVE: In a recent crossover trial, methylphenidate treatment decreased apathy in Alzheimer's disease. We further assessed this finding in the Apathy in Dementia Methylphenidate Trial (ADMET). METHOD: Six-week, randomized, double-blind, placebo-controlled multicenter trial enrolling Alzheimer's disease participants (NINCDS-ADRDA criteria) with apathy assigned to methylphenidate 20 mg daily or placebo, conducted from June 2010 to December 2011. Primary outcomes were change in Apathy Evaluation Scale (AES) score and modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGI-C). Secondary outcomes included change in Neuropsychiatric Inventory (NPI) apathy score, Mini-Mental State Examination (MMSE) score, and safety. RESULTS: 60 participants were randomly assigned (29 methylphenidate, 31 placebo). At baseline, mean (SD) age = 76 (8) years, MMSE score = 20 (5), AES score = 51 (12), NPI total score = 16 (8), and 62% of the participants (n = 37) were female. After 6 weeks' treatment, mean (SD) change in AES score was -1.9 (1.5) for methylphenidate and 0.6 (1.4) for placebo (P = .23). Odds ratio for improvement in ADCS-CGI-C was 3.7 (95% CI, 1.3 to 10.8) (P = .02), with 21% of methylphenidate versus 3% of placebo rated as moderately or markedly improved. NPI apathy score improvement was 1.8 points (95% CI, 0.3 to 3.4) greater on methylphenidate than on placebo (P = .02). MMSE trended toward improvement on methylphenidate (P = .06). There were trends toward greater anxiety and weight loss > 2% in the methylphenidate-treated group. CONCLUSIONS: Methylphenidate treatment of apathy in Alzheimer's disease was associated with significant improvement in 2 of 3 efficacy outcomes and a trend toward improved global cognition with minimal adverse events, supporting the safety and efficacy of methylphenidate treatment for apathy in Alzheimer's disease. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01117181.
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Methylphenidate has been reported to be efficacious in reducing apathy in individuals with Alzheimer's disease and apathy and fatigue in individuals with MDD.
“In support of the latter hypothesis, methylphenidate has been reported to be efficacious in reducing apathy in individuals with Alzheimer's disease (Rosenberg et al., 2013) and apathy and fatigue in individuals with MDD (Ravindran et al., 2008).”
From Lisdexamfetamine dimesylate augmentation for adults with major depressive disorder and inadequate response to antidepressant monotherapy: Results from 2 phase 3, multicenter, randomized, double-blind, placebo-controlled studies (2016) · cites this paper as Rosenberg et al., 2013
To date, successful medication trials have been re-purposing FDA drugs approved for similar or dissimilar indications.
“To date, successful medication trials have been re-purposing FDA drugs approved for similar (Porsteinsson et al., 2014) or dissimilar (Rosenberg et al., 2013) indications.”
From Neuropsychiatric symptoms in Alzheimer's disease: what might be associated brain circuits? (2015) · cites this paper as Rosenberg et al., 2013
There is evidence for the efficacy of dopaminergic agents for apathy in Alzheimer's disease.
“there is evidence for the e3cacy of dopaminergic agents for apathy in AD (Rosenberg et al., 2013)”
From Neuropsychiatric symptoms in Alzheimer's disease: what might be associated brain circuits? (2015) · cites this paper as Rosenberg et al., 2013
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References 30 · Cited by 191
- Authors
- Rosenberg, P. B., Lanctôt, K. L., Drye, L. T., Herrmann, N., Scherer, R. W., Bachman, D. L., Mintzer, J. E., & ADMET investigators
- Affiliations
- Johns Hopkins University (US)
- Corresponding author
- Mintzer, Jacobo E.
- ORCID
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2013-04-03
- Volume
- 74
- Issue
- 08
- Pages
- 810-816
- ISSN
- 0160-6689 (ISSN-L)
- PMC
- PMC3902018
- OpenAlex
- W2030994918
- Cited by
- 191
- References
- 30
- Citations by year
- 2026: 9 · 2025: 11 · 2024: 12 · 2023: 13 · 2022: 15 · 2021: 21 · 2020: 22 · 2019: 10 · 2018: 18 · 2017: 20 · 2016: 15 · 2015: 16 · 2014: 7 · 2013: 2
- FWCI
- 9.44
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Eli Lilly and Company
- Pfizer
- National Institute on Aging (K08AG029157, R01AG039384, R01AG033032, P50AG005146)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Pharmacology › Cholinesterase and Neurodegenerative Diseases
- Keywords
- methylphenidate, apathy, Alzheimer's disease, dementia, Apathy Evaluation Scale, neuropsychiatric symptoms, cognitive function, stimulant medication, adverse events, anxiety, weight loss, Neuropsychiatric Inventory, Mini-Mental State Examination, NINCDS-ADRDA criteria, treatment efficacy and safety
- MeSH terms
- Modafinil, Aged, Aged, 80 and over, Alzheimer Disease, Central Nervous System Stimulants, Benzhydryl Compounds, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Methylphenidate, Neuropsychological Tests, Psychometrics, Apathy
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