Apathy in Dementia Methylphenidate Trial 2

Summary

Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a Phase III, placebo-controlled, masked, 6 month, multi-center randomized clinical trial sponsored by National Institutes of Aging involving 200 participants with Alzheimer's disease (AD). ADMET 2 is designed to examine the efficacy and safety of methylphenidate as treatment for clinically significant apathy in AD participants. ADMET 2 will enroll participants from real world settings such as outpatient, nursing home, and assisted living facilities and will examine the effects of methylphenidate on apathy and cognition. ADMET 2 will also conduct careful safety monitoring.

Timeline

Start

2016-01

Primary completion

2020-07-15

Completion

2020-07-15

Publications

• Sankhe K, Ruthirakuhan M, Andreazza AC, Brawman-Mintzer O, Craft S, Herrmann N, Ismail Z, Lerner AJ, Levey AI, Mintzer J, Padala PR, Perin J, Porsteinsson AP, Rosenberg PB, Shade D, Tumati S, van Dyck CH, Lanctot KL. Peripheral biomarkers associated with apathy and predicting response to methylphenidate: Secondary analysis of the Apathy in Dementia Methylphenidate Trial 2 (ADMET2) study. Int Psychogeriatr. 2026 Jan 10:100181. doi: 10.1016/j.inpsyc.2025.100181. Online ahead of print.
• Lanctot KL, Chen C, Mah E, Kiss A, Li A, Shade D, Scherer RW, Vieira D, Coulibaly H, Rosenberg PB, Lerner AJ, Padala PR, Brawman-Mintzer O, van Dyck CH, Porsteinsson AP, Craft S, Levey A, Burke WJ, Mintzer J, Herrmann N. Cost consequence analysis of Apathy in Dementia Methylphenidate Trial 2 (ADMET 2). Int Psychogeriatr. 2023 Nov;35(11):664-672. doi: 10.1017/S1041610223000327. Epub 2023 Apr 17.
• Mintzer J, Lanctot KL, Scherer RW, Rosenberg PB, Herrmann N, van Dyck CH, Padala PR, Brawman-Mintzer O, Porsteinsson AP, Lerner AJ, Craft S, Levey AI, Burke W, Perin J, Shade D; ADMET 2 Research Group. Effect of Methylphenidate on Apathy in Patients With Alzheimer Disease: The ADMET 2 Randomized Clinical Trial. JAMA Neurol. 2021 Nov 1;78(11):1324-1332. doi: 10.1001/jamaneurol.2021.3356.
• Scherer RW, Drye L, Mintzer J, Lanctot K, Rosenberg P, Herrmann N, Padala P, Brawman-Mintzer O, Burke W, Craft S, Lerner AJ, Levey A, Porsteinsson A, van Dyck CH; ADMET 2 Research Group. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial. Trials. 2018 Jan 18;19(1):46. doi: 10.1186/s13063-017-2406-5.

Drugs

Indications