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

• Sponsor: St. Louis University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01825577
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Dementia; Accidental Falls; Apathy	Drug: Transdermal Methylphenidate	Phase 4

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 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia.
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transdermal Methylphenidate 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.	Drug: Transdermal Methylphenidate; 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.; Other Names: Daytrana

Outcome Measures

Primary Outcome Measures

1. Timed Get Up and Go Test - Measure of Mobility [Baseline and Post-test at 4 weeks]

   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.

Secondary Outcome Measures

1. POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance. [4 weeks]

   Performance Oriented Mobility Assessment (POMA), used to measure subject's ability to maintain balance. The test takes 10-15 minutes and involves asking subject to stand from a sitting position, standing with eyes closed and sitting down. POMA total score has a range of 0-36 where higher scores represent better performance. POMA total score is an additive combination of the 12 point Gait sub-score and the 16 point balance sub-score. A cut-off score of <21 is generally considered a fall risk among elderly people.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Legally Blind

2. History of seizures,

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

4. Known or suspected allergy to MPH or similar compounds

5. Glaucoma

6. Motor tics

7. History of significant agitation or anxiety

8. Family history of Tourette's syndrome

9. History of significant anxiety

10. History of significant agitation

11. History of significant tension.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Delmar Gardens	Saint Louis	Missouri	United States	63017

Sponsors and Collaborators

• St. Louis University

Investigators

• Principal Investigator: George T Grossberg, M.D., Saint Louis University School of Medicine Department of Neurology and Psychiatry
• Principal Investigator: Ahmed A Baig, M.D., Saint Louis University School of Medicine Department of Neurology and Psychiatry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Louis University
• ClinicalTrials.gov Identifier: NCT01825577
• Other Study ID Numbers: 23014
• First Posted: Apr 5, 2013
• Last Update Posted: Jul 24, 2018
• Last Verified: Aug 1, 2016

• Keywords provided by St. Louis University: Alzheimer Dementia; Gait
• Additional relevant MeSH terms: Dementia; Methylphenidate

Study Results

Participant Flow

Arm/Group Title	Single Arm Transdermal Methylphenidate
Arm/Group Description	Age 65 yrs and above Ability to ambulate (may use walking aid) Male or Female Clinical diagnosis of probable Alzheimer's Disease AES score >40 Identified as fall risk by nursing staff
Period Title: Overall Study
STARTED	14
COMPLETED	6
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Single Arm
Arm/Group Description	Age 65yrs and above Ability to ambulate (may use walking aid) Male or Female Clinical diagnosis of probable Alzheimer's Disease AES score >40 Identified as fall risk by nursing staff
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	14 100%
Sex: Female, Male (Count of Participants)
Female	8 57.1%
Male	6 42.9%
Region of Enrollment (participants) [Number]
United States	14 100%

Outcome Measures

1. Primary Outcome

Title	Timed Get Up and Go Test - Measure of Mobility
Description	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.
Time Frame	Baseline and Post-test at 4 weeks

Outcome Measure Data

Analysis Population Description

Elderly patients living in community nursing homes identified as fall risks with a diagnosis of probable Alzheimer's disease.

Arm/Group Title	Transdermal Methylphenidate
Arm/Group 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. Transdermal Methylphenidate: 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.
Measure Participants	6
Baseline	34.3 (30.4)
Post-Test	44.2 (18.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Transdermal Methylphenidate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.55
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.9
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.
Description	Performance Oriented Mobility Assessment (POMA), used to measure subject's ability to maintain balance. The test takes 10-15 minutes and involves asking subject to stand from a sitting position, standing with eyes closed and sitting down. POMA total score has a range of 0-36 where higher scores represent better performance. POMA total score is an additive combination of the 12 point Gait sub-score and the 16 point balance sub-score. A cut-off score of <21 is generally considered a fall risk among elderly people.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Elderly patients living in community nursing homes identified as fall risk with a diagnosis of probable Alzheimer's Disease.

Arm/Group Title	Transdermal Methylphenidate
Arm/Group 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. Transdermal Methylphenidate: 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.
Measure Participants	6
Baseline	16.7 (8.4)
Post-Test	17.8 (9.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Transdermal Methylphenidate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.67
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Single Arm Transdermal Methylphenidate
Arm/Group Description	There were no adverse events reported.
All Cause Mortality
	Single Arm Transdermal Methylphenidate
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single Arm Transdermal Methylphenidate
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Other (Not Including Serious) Adverse Events
	Single Arm Transdermal Methylphenidate
	Affected / at Risk (%)	# Events
Total	0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.