drugset / Trial / NCT00495820

Methylphenidate for Apathy in Alzheimer's Dementia: A Controlled Study

NCT00495820 ↗

Phase 4 Completed 60 enrolled VA Office of Research and Development
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of the study is to determine the efficacy of methylphenidate over placebo in treating apathy in patients with Alzheimer's dementia. Apathy is one of the earliest and most profound disturbances that occur in Alzheimer's dementia (AD). Hypotheses: 1. Methylphenidate (MPH) will improve apathy significantly more than placebo in AD. 2\. Successful treatment of apathy will improve Instrumental Activities of Daily Living (IADLs), and caregiver burden.

Timeline

Start
2007-08
Primary completion
2010-03
Completion
2010-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); Methylphenidate Group vs Placebo Group; p <0.05; Mixed Models Analysis NCT00495820 ↗

paper After adjusting for baseline, the methylphenidate group had significantly greater improvement in apathy than the placebo group at 4 weeks, 8 weeks, and 12 weeks. PMID 28945120 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 10 mg —

Indications