Trodat 1 SPECT and Dopamine Polymorphism

NCT01381302 | Completed

• 1 other identifier: 0033-11-WOMC
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

Severity of disease

Outcome Measures

Primary Outcomes (1)

• Disease severity versus genetic polymorphism

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

  1 year

Secondary Outcomes (1)

• Severity of PD compared to specific striatal DAT activity as measures by Tc-99m Trodat SPECT.

  1 year

Study Arms (1)

Parkinson

Early onset of disease

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Patients were excluded if they features secondary parkinsonism or if they were treated with medications that block dopamine receptors.

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (2)

Edith Wolfson Medical Center

Holon, Israel, 58100, Israel

Location

Edith Wolfson medical Center

Holon, 58100, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples with DNA

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Mordechai Lorberboym, MD

  Edith Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pI

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 27, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

IL (2)