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

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 initiating study drug. Phase 2 is a 2 week treatment period with 10mg of
Transdermal Methylphenidate. Phase 3 is the final two week treatment period with 15mg of
Transdermal Methylphenidate.

Measurements obtained at each phase will include:

Vital Signs (blood pressure and pulse rate) weight , Timed Get Up and Go Test (TUG) , Tinetti
Performance Oriented Mobility Assessment (POMA), Clinical Apathy Evaluation Scale (AES-C) and
the St. Louis University Mental Status Examination (SLUMS).

The primary endpoint is the change in TUG and POMA scores at end of phase 3 compared to
beginning of phase 2

Falls are a cause of substantial morbidity and mortality in patients with dementia and occur
at twice the rate of older adults without cognitive impairment. The consequences of falls in
older adults with dementia are serious; fallers with cognitive problems are approximately
five times as likely to be admitted to institutional care as people with cognitive problems
who do not fall.[3] They are also at high risk of major fall-related injuries such as
fractures and head injuries that increase mortality risk.

Walking requires paying attention to various environmental features and recovering from
postural variations to avoid stumbles or falls. Consequently, deficits in attention and
executive function are independently associated with risk of postural instability, impairment
in activities of daily living, and fall risk.

Executive function refers to higher cognitive processes that allocate attention among tasks
and a critical cognitive resource for normal walking. Lower scores on executive function
measures are associated with both dementia and a higher fall risk. Although significant
progress towards understanding the factors involved in falls has been made, the number of
falls and fall related injuries continue to increase.

Changes in aging demographics are expected to dramatically increase the aging population and
dementia prevalence, underscoring the importance of developing more effective fall prevention
strategies.

Recent studies have shown that improving certain aspects of cognition, specifically attention
and executive function, in older adults can improve mobility decline and risk of falls.
Particularly in cognitively impaired individuals, this may be critical to reducing fall risk.

Why Methylphenidate?

Pharmacological properties of psychostimulants, such as methylphenidate (MPH), are known to
increase executive function. Methylphenidate was chosen because of the studies demonstrating
the safe use of MPH for treatment of depression and apathy in the cognitively impaired
elderly and the well-studied effects of MPH on executive function and attention in children
and adults with ADHD.

Also a small study published in April 2008 in J Am Geriatric Society, evaluated the use of
methylphenidate in reducing fall risk among community living older adults. The study
concluded that among study subjects receiving methylphenidate, significant improvement in
mobility and gait assessments were observed as well as drug tolerability.

The basis for our study is to further explore the pharmacotherapeutic role of Transdermal-MPH
in reducing fall risk in dementia patients.

Mobility and gait assessment performance is strongly correlated with fall risk. Therefore we
will use subject's scores before, during and after medication administration to measure
response and evaluate use as a fall prevention strategy.

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.