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

NCT01825577 | Terminated Phase 4 Results DMC

• 1 other identifier: 23014
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Accidental Falls; Apathy

Keywords

Alzheimer Dementia; Gait

Outcome Measures

Primary Outcomes (1)

• Timed Get Up and Go Test - Measure of Mobility

  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.

  Baseline and Post-test at 4 weeks

Secondary Outcomes (1)

• POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.

  4 weeks

Study Arms (1)

Transdermal Methylphenidate

EXPERIMENTAL

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

Interventions

Transdermal Methylphenidate DRUG

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.

Also known as: Daytrana

Transdermal Methylphenidate

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age
• Ability to ambulate (may use walking aid)
• Male or Female
• Clinical diagnosis of Dementia
• Identified as fall risk by nursing staff

You may not qualify if:

• Clinically significant musculoskeletal, cardiovascular or respiratory diseases.
• Clinically significant vestibular disorder
• History of significant head trauma
• Any medically unstable condition, as determined by the PI that would expose patient to potential harm.
• 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.
• Legally Blind
• History of seizures,
• Poorly controlled hypertension, cardiac arrhythmia or cardiovascular disease, heart failure.
• Known or suspected allergy to MPH or similar compounds
• Glaucoma
• Motor tics
• History of significant agitation or anxiety
• Family history of Tourette's syndrome
• History of significant anxiety

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Delmar Gardens

St Louis, Missouri, 63017, United States

Location

MeSH Terms

Conditions

Dementia; Lethargy; Alzheimer Disease

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Ahsan Khan
• Organization: Saint Louis University

khanay@slu.edu

314-977-4826

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: April 5, 2013
• Study Start: November 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 24, 2018
• Results First Posted: August 19, 2016

Record last verified: 2016-08

Locations

US (1)