Status:
TERMINATED
Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia.
Lead Sponsor:
St. Louis University
Conditions:
Dementia
Accidental Falls
Eligibility:
All Genders
65-95 years
Phase:
PHASE4
Brief 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 c...
Detailed Description
This is an open label pilot study; consenting subjects with dementia and identified as a fall risk, who meet inclusion criteria will undergo 3 phases of involvement. Phase 1 is a 1 week period before ...
Eligibility Criteria
Inclusion
- 65- 95 years of age
- Ability to ambulate (may use walking aid)
- Male or Female
- Clinical diagnosis of Dementia
- Identified as fall risk by nursing staff
Exclusion
- Clinically significant musculoskeletal, cardiovascular or respiratory diseases.
- Clinically significant vestibular disorder
- History of significant head trauma
- Any medically unstable condition, as determined by the PI that would expose patient to potential harm.
- Patients taking medications that may interact with MPH, as determined by manufacture's package insert.
- Including but not limited to: Warfarin, anticonvulsants, MAOIs, alpha2-agonists, tri-cyclic antidepressants.
- Legally Blind
- History of seizures,
- Poorly controlled hypertension, cardiac arrhythmia or cardiovascular disease, heart failure.
- Known or suspected allergy to MPH or similar compounds
- Glaucoma
- Motor tics
- History of significant agitation or anxiety
- Family history of Tourette's syndrome
- History of significant anxiety
- History of significant agitation
- History of significant tension.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01825577
Start Date
November 1 2012
End Date
February 1 2015
Last Update
July 24 2018
Active Locations (1)
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1
Delmar Gardens
St Louis, Missouri, United States, 63017