Trodat 1 SPECT and Dopamine Polymorphism

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT01381302
• Lead Sponsor: Wolfson Medical Center

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-27
• Study Start: 2011-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease severity versus genetic polymorphism	1 year	Correlation of disease severity with polymorphism and with striatal affinity to the DAT ligand.

Secondary Outcome Measures

Name	Time	Method
Severity of PD compared to specific striatal DAT activity as measures by Tc-99m Trodat SPECT.	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).

Trial Locations

Locations (1)

Edith Wolfson medical Center; 🇮🇱 Holon, Israel