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

NCT01825577 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-07-24

Study results available
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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.

Conditions

Interventions

DRUG

Transdermal Methylphenidate

2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day.

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • George T Grossberg, M.D. · Saint Louis University School of Medicine Department of Neurology and Psychiatry

  • Ahmed A Baig, M.D. · Saint Louis University School of Medicine Department of Neurology and Psychiatry

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01825577 on ClinicalTrials.gov