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

NCT02443779 | Completed

• 1 other identifier: 15D.060
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (3)

• OCT results

  OCT measures including measurements of the thickness (microns) of specific retinal layers including RNFL, ganglion cell layer, inner plexiform layer, inner nuclear layer, outer plexiform layer, outer nuclear layer, photoreceptors, and retinal pigment epithelium.

  1 day

• DaTscan results

  Striatal binding ratios will be calculated for striatal regions of interest.

  1 day

• Clinical examination results

  UPDRS motor score

  1 day

Study Arms (2)

Early Parkinson's disease patients

All subjects will undergo a complete neuro-ophthalmological examination, including assessment of best-corrected visual acuity, ocular motility, pupillary reflexes, slit-lamp biomicroscopy, intraocular pressure (IOP) measurement, and dilated fundus examination, followed by an optical coherence tomography study. Subjects will also have a DaTscan for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging. A clinical examination will also be performed in order to document motor and cognitive functioning.

Advanced Parkinson's disease patients

All subjects will undergo a complete neuro-ophthalmological examination, including assessment of best-corrected visual acuity, ocular motility, pupillary reflexes, slit-lamp biomicroscopy, intraocular pressure (IOP) measurement, and dilated fundus examination, followed by an optical coherence tomography study. Subjects will also have a DaTscan for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging. A clinical examination will also be performed in order to document motor and cognitive functioning.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Willing and able to give informed consent.
• Between the ages of 50-80 years old.
• Male or female with idiopathic PD who fulfill UK PD Society brain bank criteria for diagnosis of Parkinson's disease.
• 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
• Later stage subjects will need to have Unified Parkinson's Disease Rating Scale motor scores of \> 20 and be \> 5 years from diagnosis
• 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.

You may not qualify if:

• Abrupt onset of Parkinsonism
• 'Other Parkinson-like syndromes (e.g. progressive supranuclear palsy, multiple system atrophy)
• Any condition that would preclude successful completion of SPECT scanning
• Use of anti-coagulant therapy
• Any clinically significant eye disease that would complicate interpretation of OCT data
• 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).
• Known sensitivity to the imaging agent or to Lugol's solution or to potassium perchlorate.
• History or presence of severe renal disease.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Wills Eye Hospital: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

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

• Jay S Schneider, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 14, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

US (1)