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Trial record 73 of 439 for:    Methylphenidate

Apathy in Dementia Methylphenidate Trial (ADMET) (ADMET)

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ClinicalTrials.gov Identifier: NCT01117181
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : May 10, 2013
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Medical University of South Carolina
Johns Hopkins University
University of Toronto
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Apathy
Alzheimer's Disease
Interventions Drug: Methylphenidate
Drug: placebo
Other: Psychosocial intervention
Enrollment 60
Recruitment Details Clinical center recruited from established outpatient clinics, from living facilities, by local physicians, and from targeted advertisements in local media. The recruitment period started June 2010 and ended October 2011.
Pre-assignment Details  
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention matching placebo and psychosocial intervention
Period Title: Overall Study
Started 29 31
Completed 28 29
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             0             2
Arm/Group Title Methylphenidate Placebo Total
Hide Arm/Group Description Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention matching placebo and psychosocial intervention Total of all reporting groups
Overall Number of Baseline Participants 29 31 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
   6.9%
4
  12.9%
6
  10.0%
>=65 years
27
  93.1%
27
  87.1%
54
  90.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 31 participants 60 participants
78  (8) 75  (9) 76  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
Female
17
  58.6%
20
  64.5%
37
  61.7%
Male
12
  41.4%
11
  35.5%
23
  38.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
United States 20 21 41
Canada 9 10 19
1.Primary Outcome
Title Apathy Evaluation Scale (AES)
Hide Description Change in score of Apathy Evaluation Scale from baseline to 6 weeks; the minimum score is 18; the maximum score is 72. Higher scores indicate more severe apathy.
Time Frame baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
Placebo and psychosocial intervention
Overall Number of Participants Analyzed 29 31
Mean (Standard Error)
Unit of Measure: units on a scale
-1.9  (1.5) 0.6  (1.4)
2.Primary Outcome
Title Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change
Hide Description Proportion of individuals improving on Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) from baseline to 6 weeks; the CGIC is a 7-point Likert scale used to rate each patient with the following scores: "marked worsening"(7), "moderate worsening" (6), "minimal worsening"(5), "no change"(4), "minimal improvement"(3), "moderate improvement"(2), "marked improvement"(1). Ratings were based on an interview with the caregiver and an examination of the patient. The CGIC requires the clinician to consider a number of aspects of apathy, such as level of initiative, level of interest, and emotional engagement.
Time Frame baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
Placebo and psychosocial intervention
Overall Number of Participants Analyzed 29 31
Measure Type: Number
Unit of Measure: percentage of participants who improve
21 3
3.Secondary Outcome
Title Digit Span
Hide Description Change in Digit Span from baseline to 6 weeks. The Wechsler Adult Intelligence Scale – Revised Digit Span is used to assess auditory attention and working memory. Both forward and backward span is assessed. Both tests consist of six number sequences that the psychometrist reads aloud one at a time. After each sequence is read, the participant must repeat the digits back in the same (forward) or reverse (backward) order. Scores range from 0 to 16, with higher numbers indicate better functioning.
Time Frame baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
Placebo and psychosocial intervention
Overall Number of Participants Analyzed 26 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.46  (1.55) -0.07  (1.25)
4.Secondary Outcome
Title Mini-Mental State Exam (MMSE)
Hide Description Change in Mini-Mental State Exam score from baseline to 6 weeks; this cognitive test estimates of dementia severity. Domains included orientation, memory, working memory, naming, following verbal and written commands, spontaneously writing a sentence, and copying two overlapping pentagons. The minimum MMSE score is 0; the maximum MMSE score is 30. Lower MMSE scores indicate more severe cognitive impairment.
Time Frame baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
Placebo and psychosocial intervention
Overall Number of Participants Analyzed 29 31
Mean (Standard Error)
Unit of Measure: units on a scale
1.3  (0.6) -0.3  (0.6)
5.Secondary Outcome
Title Neuropsychiatric Inventory (NPI): Apathy Subscale
Hide Description Change from baseline to 6 weeks in neuropsychiatric symptoms in apathy subscore. Frequency (ranges from 1=occasionally, less than once/week to 4 = very frequently, once or more/day or continuously) and severity (1=mild, 2=moderate, 3=severe) scales are scored based on responses from an informed caregiver involved in the patient's life. To obtain the NPI score, the severity score is multiplied by the frequency score. Range is 0 to 12. Larger numbers indicate more severe behavioral disturbance.
Time Frame baseline to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
matching placebo and psychosocial intervention
Overall Number of Participants Analyzed 29 31
Mean (Standard Error)
Unit of Measure: units on a scale
-4.4  (0.6) -2.6  (0.6)
6.Secondary Outcome
Title Vital Status
Hide Description vital status as measured by death
Time Frame vital status at 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
matching placebo and psychosocial intervention
Overall Number of Participants Analyzed 29 31
Measure Type: Number
Unit of Measure: participants who died
0 0
7.Secondary Outcome
Title Electrolytes
Hide Description Percent of participants with abnormal electrolyte values at 6 weeks as assessed by local laboratory
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One patient in the active group completed all visit 6 assessments except for the blood collection for the electrolyte sample. This patient refused this procedure.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
Placebo and psychosocial intervention
Overall Number of Participants Analyzed 27 29
Measure Type: Number
Unit of Measure: percentage of participants
Sodium 3.70 0
Potassium 14.81 10.34
Chloride 7.41 10.34
Bicarbonate 7.41 10.34
8.Secondary Outcome
Title Electrocardiogram (ECG)
Hide Description Abnormal electrocardiogram results at 6 weeks
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
matching placebo and psychosocial intervention
Overall Number of Participants Analyzed 29 31
Measure Type: Number
Unit of Measure: participants with abnormal ECG
20 15
Time Frame treatment period (i.e., 6 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention matching placebo and psychosocial intervention
All-Cause Mortality
Methylphenidate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Methylphenidate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      1/31 (3.23%)    
Blood and lymphatic system disorders     
drop in hemoglobin *  0/29 (0.00%)  0 1/31 (3.23%)  1
Gastrointestinal disorders     
abdominal pain *  1/29 (3.45%)  1 0/31 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Methylphenidate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/29 (100.00%)      29/31 (93.55%)    
Cardiac disorders     
Angina   2/29 (6.90%)  1/29 (3.45%) 
Ear and labyrinth disorders     
Dizziness   11/29 (37.93%)  7/29 (24.14%) 
Endocrine disorders     
Hair loss   2/29 (6.90%)  1/29 (3.45%) 
Eye disorders     
Blurry vision or eyesight changes   0/29 (0.00%)  3/29 (10.34%) 
Gastrointestinal disorders     
abdominal pain   6/29 (20.69%)  4/29 (13.79%) 
Dry mouth   7/29 (24.14%)  6/29 (20.69%) 
Nausea   3/29 (10.34%)  7/29 (24.14%) 
General disorders     
Drowsiness   10/29 (34.48%)  13/29 (44.83%) 
Headache   5/29 (17.24%)  4/29 (13.79%) 
Metabolism and nutrition disorders     
weight loss  [1]  10/29 (34.48%)  4/29 (13.79%) 
Anorexia   6/29 (20.69%)  5/29 (17.24%) 
Depressed appetite   8/29 (27.59%)  7/29 (24.14%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   6/29 (20.69%)  14/29 (48.28%) 
Nervous system disorders     
agitation   17/29 (58.62%)  13/29 (44.83%) 
Anxiety   17/29 (58.62%)  10/29 (34.48%) 
Dyskinesia   1/29 (3.45%)  4/29 (13.79%) 
Hyperactivity   5/29 (17.24%)  1/29 (3.45%) 
Tics (motor or verbal)   0/29 (0.00%)  4/29 (13.79%) 
Psychiatric disorders     
Aggressive behavior or hostility   9/29 (31.03%)  5/29 (17.24%) 
Depressed mood   12/29 (41.38%)  12/29 (41.38%) 
Skin and subcutaneous tissue disorders     
Skin rash, redness, or inflammation   6/29 (20.69%)  6/29 (20.69%) 
Social circumstances     
Distractibility   11/29 (37.93%)  8/29 (27.59%) 
Impaired learning   4/29 (13.79%)  7/29 (24.14%) 
Vascular disorders     
Blood pressure changes   4/29 (13.79%)  3/29 (10.34%) 
Indicates events were collected by systematic assessment
[1]
greater than 2% at week 6
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: Anne Casper, MA
Organization: Johns Hopkins
Phone: 410-955-8183
EMail: ashankli@jhsph.edu
Layout table for additonal information
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01117181     History of Changes
Other Study ID Numbers: R01AG033032-01 ( U.S. NIH Grant/Contract )
R01AG033032-01 ( U.S. NIH Grant/Contract )
First Submitted: May 4, 2010
First Posted: May 5, 2010
Results First Submitted: February 11, 2013
Results First Posted: May 10, 2013
Last Update Posted: June 12, 2018