Trial Outcomes & Findings for Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia. (NCT NCT01825577)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

Baseline and Post-test at 4 weeks

Results posted on

2018-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Transdermal Methylphenidate 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
Overall Study STARTED	14
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Transdermal Methylphenidate 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
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	1
Overall Study Withdrawn by family members	2
Overall Study Lack of Efficacy	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=14 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Post-test at 4 weeks

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

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.

Outcome measures

Outcome measures
Measure	Transdermal Methylphenidate n=6 Participants 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.
Timed Get Up and Go Test - Measure of Mobility Baseline	34.3 seconds Standard Deviation 30.4
Timed Get Up and Go Test - Measure of Mobility Post-Test	44.2 seconds Standard Deviation 18.1

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Outcome measures
Measure	Transdermal Methylphenidate n=6 Participants 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.
POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance. Baseline	16.7 Units on a scale Standard Deviation 8.4
POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance. Post-Test	17.8 Units on a scale Standard Deviation 9.8

Adverse Events

Single Arm Transdermal Methylphenidate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ahsan Khan

Saint Louis University

Phone: 314-977-4826

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place