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Trial record 76 of 439 for:    Methylphenidate

Methylphenidate for Apathy in Alzheimer's Dementia: A Controlled Study

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ClinicalTrials.gov Identifier: NCT00495820
Recruitment Status : Completed
First Posted : July 3, 2007
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Alzheimer's Disease
Apathy
Dementia
Interventions Drug: Methylphenidate
Other: Placebo
Enrollment 60
Recruitment Details 60 subjects meeting the inclusion and exclusion criteria were recruited from outpatient clinics at the Nebraska Western Iowa Health Care System between 2006-2009.
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description

Methylphenidate

Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study.

Placebo

Placebo: Standard inactive pill.

Period Title: Overall Study
Started 30 30
Completed 29 29
Not Completed 1 1
Reason Not Completed
Adverse Event             1             1
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

Methylphenidate

Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study.

Placebo

Placebo: Standard inactive pill.

Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
77.5  (7.9) 76.1  (8.4) 76.6  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
30
 100.0%
30
 100.0%
60
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
Apathy Evaluation Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
51.9  (7.1) 47.6  (5.8) 49.7  (6.8)
[1]
Measure Description: Range: 18-72 Higher scores indicate worse apathy
Mini-mental State Examination (MMSE)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
23.7  (2.5) 24  (2.6) 23.8  (2.5)
[1]
Measure Description: Range 0-30. Higher scores indicate better cognition
Modified Mini-Mental State Examination (3MS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
80.1  (9) 82.6  (10) 81.3  (9.5)
[1]
Measure Description: Range 0-100. Higher scores indicate better cognition
Activities of Daily Living   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
21.3  (2.7) 22.9  (2.2) 22  (2.6)
[1]
Measure Description: Range 0-24. Higher scores indicate better independence in performing activities of daily living.
The Executive Interview (EXIT-25)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
16.9  (6.3) 16.8  (6.6) 16.8  (6.4)
[1]
Measure Description: Range: 0-50, higher scores indicate worsening of executive function.
Zarit Burden Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
28.1  (13) 25.3  (13.3) 26.9  (13)
[1]
Measure Description: Range 0-88. Higher scores indicate higher caregiver burden.
Clinical Global Impression-severity (CGI-S)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
5.5  (0.6) 5.1  (0.6) 5.3  (0.6)
[1]
Measure Description: Range 0-7, higher scores indicating worsening of condition.
1.Primary Outcome
Title Apathy Evaluation Scale Score at 12 Weeks
Hide Description The Apathy Evaluation Scale (AES) has been specifically developed to assess apathy and discriminate it from depression. This 18 item scale with score ranging from 18 to 72, assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks. Higher scores indicate worsening apathy.
Time Frame At 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Group Placebo Group
Hide Arm/Group Description:
Subjects randomized to this group received methylphenidate
Subjects randomized to this group received placebo
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
38.2  (9.1) 43.6  (7.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Mini-mental State Examination (MMSE) at 12 Weeks
Hide Description Mini-mental State Examination (MMSE) is a commonly used screening measure for cognition with questions pertaining to orientation, registration, recall, visuo-spatial construction, attention span etc. Score on MMSE ranges from 0-30, higher scores indicating improving cognition
Time Frame At 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Group Placebo Group
Hide Arm/Group Description:
Subjects randomized to this group received methylphenidate
Subjects randomized to this group received placebo
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
25.8  (2.7) 23.6  (4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Clinical Global Impression
Hide Description The Clinical Global Impression scale is an observational scale of global evaluation, which assesses the change in degree of illness in relation to the original assessment. The severity sub-scale reported below ranges from 1-7 wherein higher scores indicate worsening severity of illness.
Time Frame At 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Group Placebo Group
Hide Arm/Group Description:
Subjects randomized to this group received methylphenidate
Subjects randomized to this group received placebo
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.9  (1.1) 4.8  (0.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methylphenidate Group Placebo Group
Hide Arm/Group Description Subjects randomized to this group received methylphenidate Subjects randomized to this group received methylphenidate
All-Cause Mortality
Methylphenidate Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Methylphenidate Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Methylphenidate Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/30 (46.67%)      16/30 (53.33%)    
Cardiac disorders     
Increased blood pressure   2/30 (6.67%)  3 1/30 (3.33%)  1
Gastrointestinal disorders     
Nausea   5/30 (16.67%)  7 4/30 (13.33%)  4
Weight loss   2/30 (6.67%)  2 1/30 (3.33%)  1
Nervous system disorders     
headache   3/30 (10.00%)  3 5/30 (16.67%)  6
restlessness   1/30 (3.33%)  1 3/30 (10.00%)  3
Psychiatric disorders     
Insomnia   1/30 (3.33%)  1 2/30 (6.67%)  3
Indicates events were collected by systematic assessment
Small sample size and short duration of the study are two important limitations of the study. All male subjects in the study also make it difficult to generalize the results.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prasad Padala, MD, MS, Associate Director for Clinical Programs, GRECC
Organization: Central Arkansas Veterans Healthcare System
Phone: 5012572537
EMail: prasad.padala@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00495820     History of Changes
Other Study ID Numbers: MHBB-011-06F
First Submitted: July 2, 2007
First Posted: July 3, 2007
Results First Submitted: January 21, 2014
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015