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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443779
• Other study ID #: 15D.060
• Status: Completed
• Start date: December 2015
• Est. completion date: July 2018

Study information

• Verified date: April 2019
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Wills Eye Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	DaTscan results	Striatal binding ratios will be calculated for striatal regions of interest.	1 day
Primary	Clinical examination results	UPDRS motor score	1 day