The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial
Abstract Background Alzheimer’s disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically le...
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doaj-a9764bfa127149a1814218cb503dbdec2020-11-25T00:10:48ZengBMCTrials1745-62152018-01-0119111510.1186/s13063-017-2406-5The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trialRoberta W. Scherer0Lea Drye1Jacobo Mintzer2Krista Lanctôt3Paul Rosenberg4Nathan Herrmann5Prasad Padala6Olga Brawman-Mintzer7William Burke8Suzanne Craft9Alan J. Lerner10Allan Levey11Anton Porsteinsson12Christopher H. van Dyck13the ADMET 2 Research GroupJohns Hopkins University Bloomberg School of Public HealthJohns Hopkins University Bloomberg School of Public HealthMedical University of South Carolina and Ralph H. Johnson Veterans Administration Medical CenterSunnybrook Research InstituteJohns Hopkins University School of MedicineSunnybrook Research InstituteUniversity of Arkansas for Medical Science, Central Arkansas Veterans Healthcare SystemMedical University of South Carolina and Ralph H. Johnson Veterans Administration Medical CenterBanner Alzheimer’s InstituteWake Forest University School of MedicineUniversity Hospitals – Case Western Reserve UniversityEmory UniversityUniversity of RochesterYale UniversityAbstract Background Alzheimer’s disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically leads to a worse quality of life and greater burden for caregivers. Treatment options for apathy in AD are limited, but studies have examined the use of the amphetamine, methylphenidate. The Apathy in Dementia Methylphenidate Trial (ADMET) found that treatment of apathy in AD with methylphenidate was associated with significant improvement in apathy in two of three outcome measures, some evidence of improvement in global cognition, and minimal adverse events. However, the trial only enrolled 60 participants who were followed for only 6 weeks. A larger, longer-lasting trial is required to confirm these promising findings. Methods The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a phase III, placebo-controlled, masked, 6-month, multi-center, randomized clinical trial targeted to enroll 200 participants with AD and apathy. Participants are randomly assigned 1:1 to 20 mg methylphenidate per day prepared as four over-encapsulated tablets or to matching placebo. The primary outcomes include (1) the mean difference in the Neuropsychiatric Inventory Apathy subscale scores measured as change from baseline to 6 months, and (2) the odds of having a given rating or better on the modified AD Cooperative Study Clinical Global Impression of Change ratings at month 6 compared with the baseline rating. Other outcomes include change in cognition, safety, and cost-effectiveness measured at monthly follow-up visits up to 6 months. Discussion Given the prevalence of apathy in AD and its impact on both patients and caregivers, an intervention to alleviate apathy would be of great benefit to society. ADMET 2 follows on the promising results from the original ADMET to evaluate the efficacy of methylphenidate as a treatment for apathy in AD. With a larger sample size and longer follow up, ADMET 2 is poised to confirm or refute the original ADMET findings. Trial registration ClinicalTrials.gov, NCT02346201 . Registered on 26 January 2015.http://link.springer.com/article/10.1186/s13063-017-2406-5 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Roberta W. Scherer Lea Drye Jacobo Mintzer Krista Lanctôt Paul Rosenberg Nathan Herrmann Prasad Padala Olga Brawman-Mintzer William Burke Suzanne Craft Alan J. Lerner Allan Levey Anton Porsteinsson Christopher H. van Dyck the ADMET 2 Research Group |
spellingShingle |
Roberta W. Scherer Lea Drye Jacobo Mintzer Krista Lanctôt Paul Rosenberg Nathan Herrmann Prasad Padala Olga Brawman-Mintzer William Burke Suzanne Craft Alan J. Lerner Allan Levey Anton Porsteinsson Christopher H. van Dyck the ADMET 2 Research Group The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial Trials |
author_facet |
Roberta W. Scherer Lea Drye Jacobo Mintzer Krista Lanctôt Paul Rosenberg Nathan Herrmann Prasad Padala Olga Brawman-Mintzer William Burke Suzanne Craft Alan J. Lerner Allan Levey Anton Porsteinsson Christopher H. van Dyck the ADMET 2 Research Group |
author_sort |
Roberta W. Scherer |
title |
The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial |
title_short |
The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial |
title_full |
The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial |
title_fullStr |
The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial |
title_full_unstemmed |
The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial |
title_sort |
apathy in dementia methylphenidate trial 2 (admet 2): study protocol for a randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2018-01-01 |
description |
Abstract Background Alzheimer’s disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically leads to a worse quality of life and greater burden for caregivers. Treatment options for apathy in AD are limited, but studies have examined the use of the amphetamine, methylphenidate. The Apathy in Dementia Methylphenidate Trial (ADMET) found that treatment of apathy in AD with methylphenidate was associated with significant improvement in apathy in two of three outcome measures, some evidence of improvement in global cognition, and minimal adverse events. However, the trial only enrolled 60 participants who were followed for only 6 weeks. A larger, longer-lasting trial is required to confirm these promising findings. Methods The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a phase III, placebo-controlled, masked, 6-month, multi-center, randomized clinical trial targeted to enroll 200 participants with AD and apathy. Participants are randomly assigned 1:1 to 20 mg methylphenidate per day prepared as four over-encapsulated tablets or to matching placebo. The primary outcomes include (1) the mean difference in the Neuropsychiatric Inventory Apathy subscale scores measured as change from baseline to 6 months, and (2) the odds of having a given rating or better on the modified AD Cooperative Study Clinical Global Impression of Change ratings at month 6 compared with the baseline rating. Other outcomes include change in cognition, safety, and cost-effectiveness measured at monthly follow-up visits up to 6 months. Discussion Given the prevalence of apathy in AD and its impact on both patients and caregivers, an intervention to alleviate apathy would be of great benefit to society. ADMET 2 follows on the promising results from the original ADMET to evaluate the efficacy of methylphenidate as a treatment for apathy in AD. With a larger sample size and longer follow up, ADMET 2 is poised to confirm or refute the original ADMET findings. Trial registration ClinicalTrials.gov, NCT02346201 . Registered on 26 January 2015. |
url |
http://link.springer.com/article/10.1186/s13063-017-2406-5 |
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