MedDataX Logo

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 ID: NCT01785628

Last Updated: 2013-08-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Sarcosine (also called N-methylglycine) is an endogenous GlyT-1 inhibitor. By blocking glycine uptake, sarcosine increases synaptic glycine concentration to enhance NMDA receptor function. NMDA receptor, a subtype of ionotropic glutamate receptors, serves important functions in the brain, including learning, memory, cognition, and neural plasticity under physiological conditions and contributes to neurodegeneration in pathophysiological processes. NMDA receptor represents collectively a group of heteromeric tetramers. Every NMDA receptor is a protein complex, typically composed of two NR1 subunits and two NR2 subunits that together form the NMDA receptor ion channel. It requires two receptor agonists (glutamate for the NR2 binding site and glycine for the NR1 binding site) to open the ion channel for NMDA receptor activation. Clinically, modulation through the NMDA-NR1-glycine site is preferred to avoid the excitotoxicity associated with the glutamate site activation.8 In addition, recent animal studies have shown that dopamine secretion can be enhanced by either blocking the striatal NR2 or by activation of the NMDA-receptor glycine site. In the project, we will focus on pharmacological enhancement of NMDA-glycine receptor function based on increasing synaptic glycine concentration by sarcosine administration to examine whether enhancing NMDA-glycine receptor activity can improve the neuropsychiatric symptoms, cognition and hopefully motor function in PD-D patients

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease With Dementia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Parkinson's disease dementia NMDA event related potential Bereitschaftspotential

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sarcosine capsule

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

Group Type EXPERIMENTAL

Sarcosine Capsule

Intervention Type 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.

Placebo capsule

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

Group Type PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type DIETARY_SUPPLEMENT

Placebo is dextrin composition.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo Capsule

Placebo is dextrin composition.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chon-Haw Tsai

The Chief, Department of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chon-Haw Tsai, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

China Medical University Hospital/Neuro Depart.

Taichung, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24612097 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DMR98-IRB-296

Identifier Type: -

Identifier Source: org_study_id