Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Trodat 1 SPECT and Dopamine Polymorphism

This study has been completed.
Information provided by (Responsible Party):
Mordechai Lorberboym Prof, Wolfson Medical Center Identifier:
First received: June 14, 2011
Last updated: February 8, 2016
Last verified: February 2016

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.

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:

Further study details as provided by Mordechai Lorberboym Prof, Wolfson Medical Center:

Primary Outcome Measures:
  • Disease severity versus genetic polymorphism [ Time Frame: 1 year ]
    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 ]
    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

Enrollment: 90
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01381302

Edith Wolfson medical Center
Holon, Israel, 58100
Sponsors and Collaborators
Wolfson Medical Center
Principal Investigator: Mordechai Lorberboym, MD Edith Wolfson Medical Center
  More Information

Responsible Party: Mordechai Lorberboym Prof, pI, Wolfson Medical Center Identifier: NCT01381302     History of Changes
Other Study ID Numbers: 0033-11-WOMC
Study First Received: June 14, 2011
Last Updated: February 8, 2016

Keywords provided by Mordechai Lorberboym Prof, 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
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents processed this record on May 25, 2017