Clinical trial NCT02443779: Relationship Between Symptoms, Retinal Morphology, and the Nigrostriatal Dopamine System in Parkinson's Disease
Official title: Relationship Between Symptom Severity, Retinal Morphology, and the Nigrostriatal Dopamine System in the Brain in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Wills Eye Hospital
First posted: 2015-05-14
Enrollment: 7
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be Parkinson's disease patients (Hoehn and Yahr stage 1 - 3). One study group will be subjects (N = 6) with early PD who will be within 3 years from diagnosis and not requiring dopaminergic therapy. These subjects will need to have Unified Parkinson's Disease Rating Scale motor scores of 10 - 15. The second study group will be subjects (N = 6) with more advanced PD and will have had PD for at least 5 years and will need to have Unified Parkinson's Disease Rating Scale motor scores of \> 20.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: OCT results
timeFrame: 1 day
measure: DaTscan results
timeFrame: 1 day
measure: Clinical examination results
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Jay S Schneider, PhD
role: PRINCIPAL_INVESTIGATOR
References: