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NCT01825577 · ClinicalTrials.gov registry record · Phase 4
Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia.
A Phase 4 study, sponsored by St. Louis University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT01825577: Clinical Trial Phase 4 study, sponsored by St. Louis University.
NCT01825577 is a Phase 4 study that was terminated before completion, run by St. Louis University. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01825577, a Phase 4 study, was terminated before completion, sponsored by St. Louis University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
Timed Get Up and Go Test (TUG), is used to evaluate the ability to walk by measuring the time it takes to rise from a chair, walk 10 feet, turn around, walk back to the chair, and sit down. The TUG test takes less than 5 minutes to complete. Scored as seconds required to complete the task.
Interventions
- DRUG Transdermal Methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-11 |
| Est. Completion | 2015-02 |
| Phase | Phase 4 |
Why NCT01825577 stopped before completion
NCT01825577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Transdermal Methylphenidate is the first listed.
NCT01825577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01825577 about?
NCT01825577 is a clinical study titled "Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia.". 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 ...
What is the current status of trial NCT01825577?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2012-11. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01825577?
The interventions under investigation include: Transdermal Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT01825577?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01825577's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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