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

• Status: Terminated
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Louis University
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

1. 65- 95 years of age

2. Ability to ambulate (may use walking aid)

3. Male or Female

4. Clinical diagnosis of Dementia

5. Identified as fall risk by nursing staff

Exclusion Criteria:

1. Clinically significant musculoskeletal, cardiovascular or respiratory diseases.

2. Clinically significant vestibular disorder

3. History of significant head trauma

4. Any medically unstable condition, as determined by the PI that would expose patient to potential harm.

5. 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.

6. Legally Blind

7. History of seizures,

8. Poorly controlled hypertension, cardiac arrhythmia or cardiovascular disease, heart failure.

9. Known or suspected allergy to MPH or similar compounds

10. Glaucoma

11. Motor tics

12. History of significant agitation or anxiety

13. Family history of Tourette's syndrome

14. History of significant anxiety

15. History of significant agitation

16. History of significant tension.