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OpenTrials
Completed

NCT Number: NCT02443779

Relationship Between Symptoms, Retinal Morphology, and the Nigrostriatal Dopamine System 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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. OCT results

    Time frame: 1 day

    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.

  2. DaTscan results

    Time frame: 1 day

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

  3. Clinical examination results

    Time frame: 1 day

    UPDRS motor score

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Wills Eye Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 14, 2015
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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