N/A
N=30
The Impact of Pharmacological and Electric Modulation of NMDA Pathway on the Cognitive Flexibility and Volitional Movement Preparation in Patients With Parkinson's Disease
Parkinson's Disease With Dementia
Bottom Line
View on ClinicalTrials.gov: NCT01785628 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Change in Unified Parkinson's Disease Rating Scale (UPDRS) From Baseline to 8 Weeks. — 71.6; 66.7; 67.9; 65.2 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sarcosine Capsule (Dietary_supplement); Placebo Capsule (Dietary_supplement)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- China Medical University Hospital
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) From Baseline to 8 Weeks. |
71.6; 66.7; 67.9; 65.2; 69.3; 67.6 | — |
| SECONDARY Change in Cognitive Abilities Screening Instrument (CASI) From Baseline to 8 Weeks. |
50.9; 63.9; 53.1; 63.9; 52.4; 63.9 | — |
| SECONDARY Change in Clinical Dementia Rating (CDR) From Baseline to 8 Weeks. |
2.3; 1.1; 2.1; 1.1; 2.0; 1.1 | — |
| SECONDARY Change in Neuropsychiatry Inventory (NPI) From Baseline to 8 Weeks. |
18.4; 14.9; 14.8; 14.1; 12.4; 11.7 | — |
| SECONDARY Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) From Baseline to 8 Weeks. |
10.0; 7.9; 8.4; 5.2; 7.5; 6.8 | — |
| SECONDARY Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 8 Weeks. |
11.8; 7.6; 9.9; 7.6; 10.1; 7.8 | — |
| SECONDARY Change in Beck Depression Inventory-II (BDI-II) From Baseline to 8 Weeks. |
14.3; 9.9; 15.6; 10.5; 15.8; 10.2 | — |
| SECONDARY Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 8 Weeks. |
68.0; 64.8; 67.9; 60.9; 65.9; 60.9 | — |
Summary
The project will investigate the effect of pharmacological and electric modulation of N-methyl-D-aspartate (NMDA) pathway on the cognitive flexibility and volitional movement preparation in patients with Parkinson's disease (PD).
Eligibility Criteria
Inclusion Criteria
- The diagnosis of PD-D will be based on the criteria proposed by 2007 movement disorders PD-D task force. (Emre M et.al. Mov Disord 2007; 22:1689-1707)
Exclusion Criteria
- Acute confusion due to systemic illnesses or drug intoxication.
- Major depression
- Features compatible with "Probable Vascular dementia.
- Patient who is pregnant.
Data sourced from ClinicalTrials.gov (NCT01785628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.