Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia.
Condition: Dementia; Accidental Falls; Apathy
MeSH terms: Dementia
Intervention: Transdermal Methylphenidate
Intervention description: 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.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 65 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Alzheimer Dementia; Gait

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.
    

Eligibility 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.