CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
Methylphenidate +1 moredrug
Likely dose
Methylphenidate 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02346201
NCT02346201Phase 3Completed

Apathy in Dementia Methylphenidate Trial 2

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Jan 26, 2015·Updated Jun 13, 2023

In Brief

A Phase 3 clinical trial evaluating Methylphenidate and Placebo for Apathy and Alzheimer's Disease. Completed, enrolled 200 participants across 10 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 26, 2015
Enrollment StartJan 1, 2016
Primary CompletionJul 15, 2020
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 11.4 years ago

Interventions

Methylphenidatedrug

Two 5mg methylphenidate over-encapsulated drug taken twice a day for 6 months (total of 20 mg methylphenidate per day), and psychosocial intervention

Placebodrug

Two over-encapsulated placebo taken twice a day for 6 months and psychosocial intervention