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N/A Completed N=30 Randomized Quadruple-blind Supportive Care

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
Source: ClinicalTrials.gov NCT01785628 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: 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

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).

Outcome Measures

OutcomeResultp-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

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.
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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