Trodat 1 SPECT and Dopamine Polymorphism

NCT ID: NCT01381302

Last Updated: 2016-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Parkinson

Early onset of disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mordechai Lorberboym Prof

pI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mordechai Lorberboym, MD

Role: PRINCIPAL_INVESTIGATOR

Edith Wolfson Medical Center

Locations

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Edith Wolfson Medical Center

Holon, Israel, Israel

Site Status

Edith Wolfson medical Center

Holon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0033-11-WOMC

Identifier Type: -

Identifier Source: org_study_id

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