Trial Outcomes & Findings for The Impact of Pharmacological and Electric Modulation of NMDA Pathway on the Cognitive Flexibility and Volitional Movement Preparation in Patients With Parkinson's Disease (NCT NCT01785628)
NCT ID: NCT01785628
Last Updated: 2013-08-22
Results Overview
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.
COMPLETED
NA
30 participants
baseline to 8 weeks.
2013-08-22
Participant Flow
Date of recruitment period: 05-Aug-2010 to 08-Jun-2012 Type of location: Hospital, Medical China Universities, Neurology clinic.
The diagnosis of PD-D was based on the criteria proposed by 2007 movement disorders PD-D task force. 30 patients were enrolled.
Participant milestones
| Measure |
Sarcosine Capsule
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
|
Placebo Capsule
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Sarcosine Capsule
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
|
Placebo Capsule
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
The Impact of Pharmacological and Electric Modulation of NMDA Pathway on the Cognitive Flexibility and Volitional Movement Preparation in Patients With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Sarcosine Capsule
n=15 Participants
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
|
Placebo Capsule
n=15 Participants
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age Continuous
|
76.3 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
77.3 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
76.8 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 8 weeks.Population: 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.
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.
Outcome measures
| Measure |
Sarcosine Capsule
n=15 Participants
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
|
Placebo Capsule
n=15 Participants
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
|
|---|---|---|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) From Baseline to 8 Weeks.
baseline
|
71.6 Scores on a scale
Standard Deviation 21.8
|
66.7 Scores on a scale
Standard Deviation 23.1
|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) From Baseline to 8 Weeks.
V1(2-week)
|
67.9 Scores on a scale
Standard Deviation 20.9
|
65.2 Scores on a scale
Standard Deviation 24
|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) From Baseline to 8 Weeks.
V2(4-week)
|
69.3 Scores on a scale
Standard Deviation 22.5
|
67.6 Scores on a scale
Standard Deviation 22.4
|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) From Baseline to 8 Weeks.
V3(8-week)
|
71.3 Scores on a scale
Standard Deviation 25.1
|
68.3 Scores on a scale
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: baseline to 8 weeksPopulation: ITT Population
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.
Outcome measures
| Measure |
Sarcosine Capsule
n=15 Participants
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
|
Placebo Capsule
n=15 Participants
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
|
|---|---|---|
|
Change in Cognitive Abilities Screening Instrument (CASI) From Baseline to 8 Weeks.
V3(8weeks)
|
52.4 Scores on a scale
Standard Deviation 24.0
|
63.9 Scores on a scale
Standard Deviation 24.6
|
|
Change in Cognitive Abilities Screening Instrument (CASI) From Baseline to 8 Weeks.
Baseline
|
50.9 Scores on a scale
Standard Deviation 23.8
|
63.9 Scores on a scale
Standard Deviation 23.9
|
|
Change in Cognitive Abilities Screening Instrument (CASI) From Baseline to 8 Weeks.
V2(4 weeks)
|
53.1 Scores on a scale
Standard Deviation 21.8
|
63.9 Scores on a scale
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: baseline to 8 weeksPopulation: ITT Population
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.
Outcome measures
| Measure |
Sarcosine Capsule
n=15 Participants
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
|
Placebo Capsule
n=15 Participants
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
|
|---|---|---|
|
Change in Clinical Dementia Rating (CDR) From Baseline to 8 Weeks.
Baseline
|
2.3 Scores on a scale
Standard Deviation 2.1
|
1.1 Scores on a scale
Standard Deviation 1.2
|
|
Change in Clinical Dementia Rating (CDR) From Baseline to 8 Weeks.
V2(4 weeks)
|
2.1 Scores on a scale
Standard Deviation 2.0
|
1.1 Scores on a scale
Standard Deviation 1.3
|
|
Change in Clinical Dementia Rating (CDR) From Baseline to 8 Weeks.
V3(8 weeks)
|
2.0 Scores on a scale
Standard Deviation 2.1
|
1.1 Scores on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: baseline to 8 weeksPopulation: ITT Population
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.
Outcome measures
| Measure |
Sarcosine Capsule
n=15 Participants
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
|
Placebo Capsule
n=15 Participants
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
|
|---|---|---|
|
Change in Neuropsychiatry Inventory (NPI) From Baseline to 8 Weeks.
V1(2weeks)
|
14.8 Scores on a scale
Standard Deviation 13.3
|
14.1 Scores on a scale
Standard Deviation 11.9
|
|
Change in Neuropsychiatry Inventory (NPI) From Baseline to 8 Weeks.
V2(4 weeks)
|
12.4 Scores on a scale
Standard Deviation 13.9
|
11.7 Scores on a scale
Standard Deviation 11.6
|
|
Change in Neuropsychiatry Inventory (NPI) From Baseline to 8 Weeks.
V3(8 weeks)
|
18.1 Scores on a scale
Standard Deviation 13.6
|
13.3 Scores on a scale
Standard Deviation 10.4
|
|
Change in Neuropsychiatry Inventory (NPI) From Baseline to 8 Weeks.
Baseline
|
18.4 Scores on a scale
Standard Deviation 13.4
|
14.9 Scores on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: baseline to 8 weeksThe 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.
Outcome measures
| Measure |
Sarcosine Capsule
n=15 Participants
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
|
Placebo Capsule
n=15 Participants
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
|
|---|---|---|
|
Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) From Baseline to 8 Weeks.
Baseline
|
10.0 Scores on a scale
Standard Deviation 7.6
|
7.9 Scores on a scale
Standard Deviation 6.5
|
|
Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) From Baseline to 8 Weeks.
V1(2 weeks)
|
8.4 Scores on a scale
Standard Deviation 7.9
|
5.2 Scores on a scale
Standard Deviation 4.7
|
|
Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) From Baseline to 8 Weeks.
V2(4 weeks)
|
7.5 Scores on a scale
Standard Deviation 8.1
|
6.8 Scores on a scale
Standard Deviation 6.8
|
|
Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) From Baseline to 8 Weeks.
V3(8 weeks)
|
9.4 Scores on a scale
Standard Deviation 8.8
|
6.4 Scores on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: baseline to 8 weeksThe 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.
Outcome measures
| Measure |
Sarcosine Capsule
n=15 Participants
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
|
Placebo Capsule
n=15 Participants
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
|
|---|---|---|
|
Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 8 Weeks.
V1(2 weeks)
|
9.9 Scores on a scale
Standard Deviation 7.7
|
7.6 Scores on a scale
Standard Deviation 2.4
|
|
Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 8 Weeks.
Baseline
|
11.8 Scores on a scale
Standard Deviation 8.0
|
7.6 Scores on a scale
Standard Deviation 3.5
|
|
Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 8 Weeks.
V2(4 weeks)
|
10.1 Scores on a scale
Standard Deviation 7.6
|
7.8 Scores on a scale
Standard Deviation 3.9
|
|
Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 8 Weeks.
V3(8 weeks)
|
11.0 Scores on a scale
Standard Deviation 7.4
|
7.3 Scores on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: baseline to 8 weeksPopulation: ITT Population
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.
Outcome measures
| Measure |
Sarcosine Capsule
n=15 Participants
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
|
Placebo Capsule
n=15 Participants
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
|
|---|---|---|
|
Change in Beck Depression Inventory-II (BDI-II) From Baseline to 8 Weeks.
Baseline
|
14.3 Scores on a scale
Standard Deviation 10.1
|
9.9 Scores on a scale
Standard Deviation 4.2
|
|
Change in Beck Depression Inventory-II (BDI-II) From Baseline to 8 Weeks.
V1(2 weeks)
|
15.6 Scores on a scale
Standard Deviation 9.7
|
10.5 Scores on a scale
Standard Deviation 5.2
|
|
Change in Beck Depression Inventory-II (BDI-II) From Baseline to 8 Weeks.
V2(4 weeks)
|
15.8 Scores on a scale
Standard Deviation 11.2
|
10.2 Scores on a scale
Standard Deviation 4.6
|
|
Change in Beck Depression Inventory-II (BDI-II) From Baseline to 8 Weeks.
V3(8 weeks)
|
17.5 Scores on a scale
Standard Deviation 11.7
|
9.8 Scores on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: baseline to 8 weeksPopulation: ITT Population
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.
Outcome measures
| Measure |
Sarcosine Capsule
n=15 Participants
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
|
Placebo Capsule
n=15 Participants
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
|
|---|---|---|
|
Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 8 Weeks.
V2(4 weeks)
|
65.9 Scores on a scale
Standard Deviation 26.4
|
60.9 Scores on a scale
Standard Deviation 17.5
|
|
Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 8 Weeks.
V3(8 weeks)
|
63.7 Scores on a scale
Standard Deviation 28.9
|
60.1 Scores on a scale
Standard Deviation 18.2
|
|
Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 8 Weeks.
Baseline
|
68.0 Scores on a scale
Standard Deviation 28.2
|
64.8 Scores on a scale
Standard Deviation 19.5
|
|
Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 8 Weeks.
V1(2 weeks)
|
67.9 Scores on a scale
Standard Deviation 29.3
|
60.9 Scores on a scale
Standard Deviation 18.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to 8 weeks18F-FDG PET scan : 8 patients for treatment and placebo groups,respectively.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to 8 weeks\[99mTc\]TRODAT-1 : 7 patients for treatment and placebo groups, respectively.
Outcome measures
Outcome data not reported
Adverse Events
Sarcosine Capsule
Placebo Capsule
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sarcosine Capsule
n=15 participants at risk
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
|
Placebo Capsule
n=15 participants at risk
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
|
|---|---|---|
|
Nervous system disorders
dizziness
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
hypersomnia
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
Additional Information
The chief, Department of Neurology
China Medical University Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place