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Completed

NCT Number: NCT01381302

Trodat 1 SPECT and Dopamine Polymorphism

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Edith Wolfson Medical Center, Holon, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

were

  • 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
  • Patients did not use any type of anti-parkinsonian drug type, at time of DAT-scan performance and UPDRS evaluation
  • DNA sample was obtained
  • 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.

Treatment and study plan

Primary outcomes

  1. Disease severity versus genetic polymorphism

    Time frame: 1 year

    Correlation of disease severity with polymorphism and with striatal affinity to the DAT ligand.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

Association of Polymorphism in Genes Associated With Control of Dopamine Levels in Parkinson's Disease and Tc-99m-Trodat-1 SPECT Imaging.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2011
Registry last updated
Feb 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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