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Trodat 1 SPECT and Dopamine Polymorphism

This study is not yet open for participant recruitment.
Verified June 2011 by Wolfson Medical Center
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01381302
First received: June 14, 2011
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

The study population will include 100 parkinsonian patients in early stage of disease, with total duration not exeeding 5 years.

The patients will undergo neurologic examination and evaluation of disease severity using the unified PD rating scale. Subsequently a brain SPECT will be performed using Tc-99m-Trodat1.


Condition
Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Polymorphism in Genes Associated With Control of Dopamine Levels in Parkinson's Disease and Tc-99m-Trodat-1 SPECT Imaging.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • Disease severity versus genetic polymorphism [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Correlation of disease severity with polymorphism and with striatal affinity to the DAT ligand.


Secondary Outcome Measures:
  • Severity of PD compared to specific striatal DAT activity as measures by Tc-99m Trodat SPECT. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    For each striatal ROI, mean counts will be measured, and specific TRODAT uptake will be calculated, according to the following formula: Specific TRODAT uptake = (mean activity in ROI - mean Activity in occipital cortex) / mean Activity in occipital cortex).


Biospecimen Retention:   Samples With DNA

Blood samples with DNA


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Parkinson
Early onset of disease

Detailed Description:

The study sample will include 100 Israeli Jewish patients with early idiopathic PD who were not treated with anti-parkinson drugs. The clinical diagnosis will be based on the criteria of the United Kingdom Parkinson Disease Society Brain Bank.5 All patients will undergo Tc-99m-Trodat1 SPECT. The severity of the motor symptoms will be assessed with the Unified PD Rating Scale (UPDRS). Genomic DNA is extracted from peripheral blood leukocytes for genetic analysis.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

100 early Israeli PD patients Of jewish origin, males or females Undergoing DAT-scan examination in Wolfson medical center at early stage of disease, accompanied by a UPDRS evaluation at that stage,performed by a trained neurologist

Criteria

Inclusion Criteria:

Inclusion criteria were

  1. early Israeli PD patients
  2. Of jewish origin, males or females
  3. Undergoing DAT-scan examination in Wolfson medical center at early stage of disease, accompanied by a UPDRS evaluation at that stage,performed by a trained neurologist
  4. Patients did not use any type of anti-parkinsonian drug type, at time of DAT-scan performance and UPDRS evaluation
  5. DNA sample was obtained
  6. Patients were able to sign an informed consent form to participate in this study.

Exclusion Criteria:

  • Patients were excluded if they features secondary parkinsonism or if they were treated with medications that block dopamine receptors.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381302

Contacts
Contact: Ruth Djaldetti, MD 972-508-464677 [yhaimi@bezeqint.net]
Contact: Mordechai Lorberboym, MD 972-544-630930 lorberboym@wolfson.health.gov.il

Locations
Israel
Edith Wolfson medical Center Not yet recruiting
Holon, Israel, 58100
Contact: Mordechai Lorberboym, MD     972-3-5028540 ext 8540     lorberboym@wolfson.health.gov.il    
Principal Investigator: Mordechai Lorberboym, MD            
Edith Wolfson Medical Center Not yet recruiting
Holon, Israel, 58100
Contact: Rinat Hirsh     972-3-5028346 ext 8346     rinath@wolfson.health.gov.il    
Principal Investigator: Mordechai Lorberboym, MD            
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Mordechai Lorberboym, MD Edith Wolfson Medical Center
  More Information

No publications provided

Responsible Party: Mordechai Lorberboym. M.D., Edith Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01381302     History of Changes
Other Study ID Numbers: 0033-11-WOMC
Study First Received: June 14, 2011
Last Updated: June 22, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Wolfson Medical Center:
Severity of disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine
Cardiotonic Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 21, 2013