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
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease With Dementia||Dietary Supplement: Sarcosine Capsule Dietary Supplement: Placebo Capsule||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||July 2012|
Experimental: Sarcosine capsule
Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
Dietary Supplement: Sarcosine Capsule
Sarcosine is a glycine transporter-1 (GlyT-1) inhibitor. By blocking glycine uptake, sarcosine increases synaptic glycine concentration to enhance NMDA receptor function.
Placebo Comparator: Placebo capsule
Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
Dietary Supplement: Placebo Capsule
Placebo is dextrin composition.
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) From Baseline to 8 Weeks. [ Time Frame: baseline to 8 weeks. ]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.
- Change in Cognitive Abilities Screening Instrument (CASI) From Baseline to 8 Weeks. [ Time Frame: baseline to 8 weeks ]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.
- Change in Clinical Dementia Rating (CDR) From Baseline to 8 Weeks. [ Time Frame: baseline to 8 weeks ]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.
- Change in Neuropsychiatry Inventory (NPI) From Baseline to 8 Weeks. [ Time Frame: baseline to 8 weeks ]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.
- Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) From Baseline to 8 Weeks. [ Time Frame: baseline to 8 weeks ]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.
- Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 8 Weeks. [ Time Frame: baseline to 8 weeks ]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.
- Change in Beck Depression Inventory-II (BDI-II) From Baseline to 8 Weeks. [ Time Frame: baseline to 8 weeks ]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.
- Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 8 Weeks. [ Time Frame: baseline to 8 weeks ]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.
- Change in Brain Imaging by 18F-FDG PET From Baseline to 8 Weeks. [ Time Frame: baseline to 8 weeks ]18F-FDG PET scan : 8 patients for treatment and placebo groups,respectively.
- Change in Brain Imaging by [99mTc]TRODAT-1 From Baseline to 8 Weeks. [ Time Frame: baseline to 8 weeks ][99mTc]TRODAT-1 : 7 patients for treatment and placebo groups, respectively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785628
|China Medical University Hospital/Neuro Depart.|
|Principal Investigator:||Chon-Haw Tsai, MD, PHD||Department of Neurology, China Medical University Hospital, Taichung, Taiwan|