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Trial record 21 of 441 for:    Methylphenidate

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

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ClinicalTrials.gov Identifier: NCT01825577
Recruitment Status : Terminated (Administrative Reasons)
First Posted : April 5, 2013
Results First Posted : August 19, 2016
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
St. Louis University

Tracking Information
First Submitted Date  ICMJE March 13, 2013
First Posted Date  ICMJE April 5, 2013
Results First Submitted Date  ICMJE April 7, 2016
Results First Posted Date  ICMJE August 19, 2016
Last Update Posted Date July 24, 2018
Study Start Date  ICMJE November 2012
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
Timed Get Up and Go Test - Measure of Mobility [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
Change from baseline in mobility and gait assessments at 4 weeks [ Time Frame: 4 weeks ]
Timed Up and Go and Tinetti Performance Oriented Mobility assessment scores at baseline compared to assessment scores at 4 weeks. Measuring change.
Change History Complete list of historical versions of study NCT01825577 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
Change from baseline in Apathy Evaluation Scale score at 4 weeks [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia.
Official Title  ICMJE Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia.
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Dementia
  • Accidental Falls
  • Apathy
Intervention  ICMJE 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 Name: Daytrana
Study Arms  ICMJE 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.
Intervention: Drug: Transdermal Methylphenidate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 11, 2016)
14
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2013)
40
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 95 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01825577
Other Study ID Numbers  ICMJE 23014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Louis University
Study Sponsor  ICMJE St. Louis University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account St. Louis University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP