Relationship Between Symptoms, Retinal Morphology, and the Nigrostriatal Dopamine System in Parkinson's Disease



Status:Active, not recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 80
Updated:10/15/2017
Start Date:December 2015
End Date:July 2018

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Relationship Between Symptom Severity, Retinal Morphology, and the Nigrostriatal Dopamine System in the Brain in Parkinson's Disease

The purpose of this study is to examine if a correlation exists between findings from brain
imaging studies of the status of the dopamine system in the brain using DaTscan and SPECT
imaging, clinical symptoms of Parkinson's disease, and changes in the structure of the retina
as detected by optical coherence tomography (OCT) in recently diagnosed and more advanced
Parkinson's disease patients.


Inclusion Criteria:

1. Willing and able to give informed consent.

2. Between the ages of 50-80 years old.

3. Male or female with idiopathic PD who fulfill UK PD Society brain bank criteria for
diagnosis of Parkinson's disease.

4. Early stage subjects will need to have Unified Parkinson's Disease Rating Scale
(UPDRS) motor scores of < 10, be within 3 years of diagnosis, and not requiring
dopaminergic therapy

5. Later stage subjects will need to have Unified Parkinson's Disease Rating Scale motor
scores of > 20 and be > 5 years from diagnosis

6. If female, one of the following three scenarios must apply:

- at least two years post-menopausal

- surgically sterile

- negative urine pregnancy test, and following a reliable method of birth control
(oral contraceptive, intrauterine device, contraceptive implant, barrier, or
abstinence) for at least two months prior to entry, and agreeing both to follow a
reliable method of birth control, and (if relevant) to desist from breast feeding
during, and for two weeks following tracer administration.

Exclusion Criteria:

1. Abrupt onset of Parkinsonism

2. 'Other Parkinson-like syndromes (e.g. progressive supranuclear palsy, multiple system
atrophy)

3. Any condition that would preclude successful completion of SPECT scanning

4. Use of anti-coagulant therapy

5. Any clinically significant eye disease that would complicate interpretation of OCT
data

6. Use of any drugs that would alter or interfere with tracer binding for SPECT imaging
studies (ex., cocaine, amphetamines, methylphenidate, ephedrine, phentermine,
bupropion, fentanyl, selective serotonin reuptake inhibitors).

7. Known sensitivity to the imaging agent or to Lugol's solution or to potassium
perchlorate.

8. History or presence of severe renal disease.
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-503-0370
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