Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Dementia
Accidental Falls
Apathy
Intervention Drug: Transdermal Methylphenidate
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm Transdermal Methylphenidate
Hide Arm/Group Description
  1. Age 65 yrs and above
  2. Ability to ambulate (may use walking aid)
  3. Male or Female
  4. Clinical diagnosis of probable Alzheimer's Disease
  5. AES score >40
  6. Identified as fall risk by nursing staff
Period Title: Overall Study
Started 14
Completed 6
Not Completed 8
Reason Not Completed
Physician Decision             2
Withdrawal by Subject             1
Withdrawn by family members             2
Lack of Efficacy             3
Arm/Group Title Single Arm
Hide Arm/Group Description
  1. Age 65yrs and above
  2. Ability to ambulate (may use walking aid)
  3. Male or Female
  4. Clinical diagnosis of probable Alzheimer's Disease
  5. AES score >40
  6. Identified as fall risk by nursing staff
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
14
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
8
  57.1%
Male
6
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Timed Get Up and Go Test - Measure of Mobility
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: seconds
Baseline 34.3  (30.4)
Post-Test 44.2  (18.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transdermal Methylphenidate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .55
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 16.7  (8.4)
Post-Test 17.8  (9.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transdermal Methylphenidate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .67
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.1
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm Transdermal Methylphenidate
Hide Arm/Group Description There were no adverse events reported.
All-Cause Mortality
Single Arm Transdermal Methylphenidate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm Transdermal Methylphenidate
Affected / at Risk (%)
Total   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm Transdermal Methylphenidate
Affected / at Risk (%)
Total   0/14 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ahsan Khan
Organization: Saint Louis University
Phone: 314-977-4826
EMail: khanay@slu.edu
Layout table for additonal information
Responsible Party: St. Louis University
ClinicalTrials.gov Identifier: NCT01825577     History of Changes
Other Study ID Numbers: 23014
First Submitted: March 13, 2013
First Posted: April 5, 2013
Results First Submitted: April 7, 2016
Results First Posted: August 19, 2016
Last Update Posted: July 24, 2018