drugset / Trial / NCT01825577

Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia.

NCT01825577 ↗

Phase 4 Terminated 14 enrolled St. Louis University
NaSingle-groupOpen-labelPrevention

Summary

Falls in the elderly are a very common and serious health problem with devastating consequences. Those with dementia are 5 times more likely to experience falls than older people without significant cognitive impairment. Despite a growing awareness and the use of available treatments, the number of falls and fall related injuries continue to increase. It is important to develop more effective treatments to help reduce the number of falls and prevent injury. The assessments used in this study determine fall risk which predicts the likelihood of falls in the future. This study will evaluate the possible role of Methylphenidate, Ritalin, in preventing falls and improving symptoms of apathy, or indifference. Methylphenidate is FDA approved for the treatment of ADHD but is not currently approved by the FDA for preventing falls or improving apathy(lack of interest) in the elderly. The methylphenidate used in this study will be absorbed through the skin by wearing a small patch near the hip area. The specific primary aim of this open label study is to determine if use of transdermal Methylphenidate (t-MPH) causes a reduction in fall risk in patients with dementia. The hypotheses to be tested is that after receiving t-MPH for 4 weeks, subjects will show improvement in gait and mobility assessment scores when compared to gait and mobility scores at screening.

Timeline

Start
2012-11
Primary completion
2015-02
Completion
2015-02

Outcome

Outcome not reported

Stopped: “Administrative Reasons”

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 15 mg Topical

Indications