Trodat 1 SPECT and Dopamine Polymorphism

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381302
• Other study ID #: 0033-11-WOMC
• Status: Completed
• Phase: N/A
• First received: June 14, 2011
• Last updated: February 8, 2016
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2016
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Israel	Edith Wolfson medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease severity versus genetic polymorphism	Correlation of disease severity with polymorphism and with striatal affinity to the DAT ligand.	1 year	No
Secondary	Severity of PD compared to specific striatal DAT activity as measures by Tc-99m Trodat SPECT.	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).	1 year	No