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

NCT01785628 | Completed Results DMC

• 1 other identifier: DMR98-IRB-296
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Parkinson's Disease With Dementia

Keywords

Parkinson's disease; dementia; NMDA; event related potential; Bereitschaftspotential

Outcome Measures

Primary Outcomes (1)

• Change in Unified Parkinson's Disease Rating Scale (UPDRS) From 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.

  baseline to 8 weeks.

Secondary Outcomes (7)

• Change in Cognitive Abilities Screening Instrument (CASI) From Baseline to 8 Weeks.

  baseline to 8 weeks

• Change in Clinical Dementia Rating (CDR) From Baseline to 8 Weeks.

  baseline to 8 weeks

• Change in Neuropsychiatry Inventory (NPI) From Baseline to 8 Weeks.

  baseline to 8 weeks

• Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) From Baseline to 8 Weeks.

  baseline to 8 weeks

• Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 8 Weeks.

  baseline to 8 weeks

Other Outcomes (2)

• Change in Brain Imaging by 18F-FDG PET From Baseline to 8 Weeks.

  baseline to 8 weeks

• Change in Brain Imaging by [99mTc]TRODAT-1 From Baseline to 8 Weeks.

  baseline to 8 weeks

Study Arms (2)

Sarcosine capsule

EXPERIMENTAL

Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.

Dietary Supplement: Sarcosine Capsule

Placebo capsule

PLACEBO COMPARATOR

Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.

Dietary Supplement: Placebo Capsule

Interventions

Sarcosine Capsule DIETARY_SUPPLEMENT

Sarcosine is a glycine transporter-1 (GlyT-1) inhibitor. By blocking glycine uptake, sarcosine increases synaptic glycine concentration to enhance NMDA receptor function.

Sarcosine capsule

Placebo Capsule DIETARY_SUPPLEMENT

Placebo is dextrin composition.

Placebo capsule

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Acute confusion due to systemic illnesses or drug intoxication.
• Major depression
• Features compatible with "Probable Vascular dementia.
• Patient who is pregnant.

Sponsors & Collaborators

• China Medical University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

China Medical University Hospital/Neuro Depart.

Taichung, Taiwan

Location

Related Publications (1)

• Tsai CH, Huang HC, Liu BL, Li CI, Lu MK, Chen X, Tsai MC, Yang YW, Lane HY. Activation of N-methyl-D-aspartate receptor glycine site temporally ameliorates neuropsychiatric symptoms of Parkinson's disease with dementia. Psychiatry Clin Neurosci. 2014 Sep;68(9):692-700. doi: 10.1111/pcn.12175. Epub 2014 Apr 14.

  PMID: 24612097 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Dementia

Interventions

Sarcosine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

N-substituted Glycines; Glycine; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: The chief, Department of Neurology
• Organization: China Medical University Hospital

d8079@mail.cmuh.org.tw

8864-22052121

Study Officials

• Chon-Haw Tsai, MD, PHD

  Department of Neurology, China Medical University Hospital, Taichung, Taiwan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Chief, Department of Neurology

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: February 7, 2013
• Study Start: August 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 22, 2013
• Results First Posted: August 22, 2013

Record last verified: 2013-08

Locations

TW (1)