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Trial record 35 of 2441 for:    NMDA

The Impact of Pharmacological and Electric Modulation of NMDA Pathway on the Cognitive Flexibility and Volitional Movement Preparation in Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01785628
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : August 22, 2013
Last Update Posted : August 22, 2013
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chon-Haw Tsai, China Medical University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Parkinson's Disease With Dementia
Interventions Dietary Supplement: Sarcosine Capsule
Dietary Supplement: Placebo Capsule
Enrollment 30
Recruitment Details Date of recruitment period: 05-Aug-2010 to 08-Jun-2012 Type of location: Hospital, Medical China Universities, Neurology clinic.
Pre-assignment Details The diagnosis of PD-D was based on the criteria proposed by 2007 movement disorders PD-D task force. 30 patients were enrolled.
Arm/Group Title Sarcosine Capsule Placebo Capsule
Hide Arm/Group Description Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks. Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
Period Title: Overall Study
Started 15 15
Completed 13 12
Not Completed 2 3
Reason Not Completed
Lost to Follow-up             2             3
Arm/Group Title Sarcosine Capsule Placebo Capsule Total
Hide Arm/Group Description Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks. Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
   6.7%
0
   0.0%
1
   3.3%
>=65 years
14
  93.3%
15
 100.0%
29
  96.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
76.3  (5.3) 77.3  (6.6) 76.8  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
7
  46.7%
4
  26.7%
11
  36.7%
Male
8
  53.3%
11
  73.3%
19
  63.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Change in Unified Parkinson's Disease Rating Scale (UPDRS) From Baseline to 8 Weeks.
Hide Description Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline to 8 weeks. The UPDRS score has three parts, part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Each consisting of questions answered on a 0-4 point scale. The minimum total score possible is 0 and the maximum total score possible is 176. Higher scores indicating more severe symptoms.
Time Frame baseline to 8 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Population comprised all randomised patients who took at least one dose of study medication or placebo and who had a valid baseline efficacy measure and at least one post-baseline efficacy measure.
Arm/Group Title Sarcosine Capsule Placebo Capsule
Hide Arm/Group Description:
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
baseline 71.6  (21.8) 66.7  (23.1)
V1(2-week) 67.9  (20.9) 65.2  (24)
V2(4-week) 69.3  (22.5) 67.6  (22.4)
V3(8-week) 71.3  (25.1) 68.3  (21.7)
2.Secondary Outcome
Title Change in Cognitive Abilities Screening Instrument (CASI) From Baseline to 8 Weeks.
Hide Description The Cognitive Abilities Screening Instrument (CASI) has a score range of 0 to 100 and provides quantitative assessment on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, abstraction, and judgment. With a higher score indicating Symptom improvement.
Time Frame baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Sarcosine Capsule Placebo Capsule
Hide Arm/Group Description:
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 50.9  (23.8) 63.9  (23.9)
V2(4 weeks) 53.1  (21.8) 63.9  (22.5)
V3(8weeks) 52.4  (24.0) 63.9  (24.6)
3.Secondary Outcome
Title Change in Clinical Dementia Rating (CDR) From Baseline to 8 Weeks.
Hide Description The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. With a higher score indicating more severe symptoms.
Time Frame baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Sarcosine Capsule Placebo Capsule
Hide Arm/Group Description:
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 2.3  (2.1) 1.1  (1.2)
V2(4 weeks) 2.1  (2.0) 1.1  (1.3)
V3(8 weeks) 2.0  (2.1) 1.1  (1.3)
4.Secondary Outcome
Title Change in Neuropsychiatry Inventory (NPI) From Baseline to 8 Weeks.
Hide Description The NPI scale has 12 domains: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The total score ranges from 0 to 144, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and with a higher score indicating more severe symptoms.
Time Frame baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Sarcosine Capsule Placebo Capsule
Hide Arm/Group Description:
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 18.4  (13.4) 14.9  (11.2)
V1(2weeks) 14.8  (13.3) 14.1  (11.9)
V2(4 weeks) 12.4  (13.9) 11.7  (11.6)
V3(8 weeks) 18.1  (13.6) 13.3  (10.4)
5.Secondary Outcome
Title Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) From Baseline to 8 Weeks.
Hide Description The Behave-AD includes the assessment of symptoms and a global rating of caregiver distress. A total of 25 symptoms in 7 clusters are rated: paranoid and delusional ideation, hallucinations, aggressiveness, activity disturbances, diurnal rhythm disturbances, affective disturbances and anxieties, and phobias. Caregivers rate behavioral symptoms over the preceding 2 weeks on a 0 to 3 scale. The caregiver also determines a global assessment of caregiver distress on a scale of 0 to 3. The maximum score is 75 and with a higher score indicating more severe symptoms.
Time Frame baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sarcosine Capsule Placebo Capsule
Hide Arm/Group Description:
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 10.0  (7.6) 7.9  (6.5)
V1(2 weeks) 8.4  (7.9) 5.2  (4.7)
V2(4 weeks) 7.5  (8.1) 6.8  (6.8)
V3(8 weeks) 9.4  (8.8) 6.4  (6.9)
6.Secondary Outcome
Title Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 8 Weeks.
Hide Description The HAM-D is a 21-item rating scaled which includes an emphasis on behavioral symptoms and somatic complaints that neglects self-reported feelings of distress; and an intermingling of frequency and intensity of symptoms. The total score ranges from 0 to 64: ten items are ranked on a scale from 0 to 4; 9 items are ranked 0 to 2; and 2 items are ranked 0 to 3. With a higher score indicating more severe symptoms.
Time Frame baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sarcosine Capsule Placebo Capsule
Hide Arm/Group Description:
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 11.8  (8.0) 7.6  (3.5)
V1(2 weeks) 9.9  (7.7) 7.6  (2.4)
V2(4 weeks) 10.1  (7.6) 7.8  (3.9)
V3(8 weeks) 11.0  (7.4) 7.3  (3.2)
7.Secondary Outcome
Title Change in Beck Depression Inventory-II (BDI-II) From Baseline to 8 Weeks.
Hide Description The BDI-II is a 21-item self-report questionnaire assessing the current severity of depression symptoms. Each item is scored on a scale of 0 to 3 and the total score ranges from 0 to 63. With a higher score indicating more severe symptoms.
Time Frame baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Sarcosine Capsule Placebo Capsule
Hide Arm/Group Description:
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 14.3  (10.1) 9.9  (4.2)
V1(2 weeks) 15.6  (9.7) 10.5  (5.2)
V2(4 weeks) 15.8  (11.2) 10.2  (4.6)
V3(8 weeks) 17.5  (11.7) 9.8  (5.7)
8.Secondary Outcome
Title Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 8 Weeks.
Hide Description The PDQ-39 contains 39-items covering 8 discrete dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. Each question is scored on a 5-point scale and recoded to 0 to 4 for the analysis. The total score can range from 0 to 132 and with a higher score indicating more severe symptoms.
Time Frame baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Sarcosine Capsule Placebo Capsule
Hide Arm/Group Description:
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 68.0  (28.2) 64.8  (19.5)
V1(2 weeks) 67.9  (29.3) 60.9  (18.9)
V2(4 weeks) 65.9  (26.4) 60.9  (17.5)
V3(8 weeks) 63.7  (28.9) 60.1  (18.2)
9.Other Pre-specified Outcome
Title Change in Brain Imaging by 18F-FDG PET From Baseline to 8 Weeks.
Hide Description 18F-FDG PET scan : 8 patients for treatment and placebo groups,respectively.
Time Frame baseline to 8 weeks
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Change in Brain Imaging by [99mTc]TRODAT-1 From Baseline to 8 Weeks.
Hide Description [99mTc]TRODAT-1 : 7 patients for treatment and placebo groups, respectively.
Time Frame baseline to 8 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sarcosine Capsule Placebo Capsule
Hide Arm/Group Description Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks. Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
All-Cause Mortality
Sarcosine Capsule Placebo Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sarcosine Capsule Placebo Capsule
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sarcosine Capsule Placebo Capsule
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      1/15 (6.67%)    
Nervous system disorders     
dizziness  1/15 (6.67%)  1 0/15 (0.00%)  0
hypersomnia  0/15 (0.00%)  0 1/15 (6.67%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: The chief, Department of Neurology
Organization: China Medical University Hospital
Phone: 8864-22052121 ext 5035
Responsible Party: Chon-Haw Tsai, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01785628     History of Changes
Other Study ID Numbers: DMR98-IRB-296
First Submitted: June 24, 2011
First Posted: February 7, 2013
Results First Submitted: May 13, 2013
Results First Posted: August 22, 2013
Last Update Posted: August 22, 2013