DementiaPhase 4NCT01825577
Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia.
A Phase 4 study testing Transdermal Methylphenidate in people with Dementia and Accidental Falls, run by St. Louis University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Dementia, Accidental Falls, Apathy
- What is being tested?
- Transdermal Methylphenidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Feb 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65- 95 years of age
- Ability to ambulate (may use walking aid)
- Male or Female
- Clinical diagnosis of Dementia
- Identified as fall risk by nursing staff
Who cannot join
- 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.
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- 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
- History of significant agitation
- History of significant tension.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Dementia, Accidental Falls, Apathy
- Being tested
- Transdermal Methylphenidate
- Keywords
- Alzheimer Dementia, Gait
- Medical subject headings
- Dementia, Lethargy, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal MethylphenidateDrug
Also called Daytrana
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Transdermal Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Post-test at 4 weeks
Secondary outcomes (1)
POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startNov 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Administrative Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George T Grossberg, M.D., Principal investigator, Saint Louis University School of Medicine Department of Neurology and PsychiatryAhmed A Baig, M.D., Principal investigator, Saint Louis University School of Medicine Department of Neurology and Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825577
- Sponsor's protocol ID
- 23014
- Status last verified
- Aug 2016
- First submitted
- 13 Mar 2013
- Last updated
- 24 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia.
- ClinicalTrials.gov ID
- NCT01825577
- Acronym / sponsor ID
- 23014
- Conditions
- Dementia, Accidental Falls, Apathy
- Keywords
- Alzheimer Dementia, Gait
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative Reasons
- Enrolment
- 14 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Posted 19 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transdermal Methylphenidate | Experimental | Drug: Transdermal Methylphenidate2 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. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65- 95 years of age
- Ability to ambulate (may use walking aid)
- Male or Female
- Clinical diagnosis of Dementia
- Identified as fall risk by nursing staff
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal MethylphenidateAlso: Daytrana2 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 |
Primary outcome
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.
1 secondary outcome
POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George T Grossberg, M.D. principal investigator
Saint Louis University School of Medicine Department of Neurology and Psychiatry
Ahmed A Baig, M.D. principal investigator
Saint Louis University School of Medicine Department of Neurology and Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transdermal Methylphenidate in people with Dementia and Accidental Falls, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Get Up and Go Test - Measure of Mobility (time frame: Baseline and Post-test at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.