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Retinal Abnormalities as Biomarker of Disease Progression and Early Diagnosis of Parkinson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02640339
Recruitment Status : Recruiting
First Posted : December 28, 2015
Last Update Posted : December 3, 2019
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
  • To determine whether retinal abnormalities, as measured by high definition optical coherence tomography (HD-OCT) and visual electrophysiology techniques can be used as a clinical biomarker to monitor disease progression overtime in patients with Parkinson disease.
  • To establish whether these measures can be used to identify patients with PD in the premotor phase.
  • To define the rate of progression of retinal abnormalities in PD (both in the motor and premotor stages) for potential use as a clinical outcome measure

Condition or disease
Parkinson Disease Multiple System Atrophy REM Sleep Behavior Disorder Pure Autonomic Failure Dementia With Lewy Bodies

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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Retinal Abnormalities as Biomarker of Disease Progression and Early Diagnosis of Parkinson Disease
Study Start Date : February 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Parkinson Disease
Parkinson's disease is a progressive disorder of the nervous system that affects movement. It develops gradually, with alpha-synuclein deposits in neurons which aggregate into Lewy bodies.
Mutiple system atrophy
is a degenerative neurological disorder. MSA is associated with the degeneration of nerve cells in specific areas of the brain. This cell degeneration causes problems with movement, balance, and autonomic functions of the body such as bladder control or blood-pressure regulation. Neuronal death probably occurs as a consequence of alpha-synuclein aggregation in oligodendroglia.
REM sleep behavior disorder
a sleep disorder in which you physically act out vivid, often unpleasant dreams with vocal sounds and sudden, often violent arm and leg movements
dementia with Lewy bodies

causes a progressive decline in mental abilities.

It may also cause visual hallucinations, which generally take the form of objects, people or animals that aren't there. This can lead to unusual behavior such as having conversations with deceased loved ones.

Another indicator of Lewy body dementia may be significant fluctuations in alertness and attention, which may include daytime drowsiness or periods of staring into space. And, like Parkinson's disease, Lewy body dementia can result in rigid muscles, slowed movement and tremors.

Pure autonomic failure
Pure autonomic failure is dysfunction of many of the processes controlled by the autonomic nervous system, such as control of blood pressure•Blood pressure may decrease when people stand, and they may sweat less and may have eye problems, retain urine, become constipated, or lose control of bowel movements
Healthy controls
Healthy normals with no neurological involvement

Primary Outcome Measures :
  1. Retinal nerve fiber layer (RNFL) thickness [ Time Frame: Every 6 months from baseline to 3 years ]
    The results of the RNFL thickness will be expressed in microns in different zones around the optic nerve: temporal, superior, nasal, inferior and global.

  2. Retinal ganglion cell layer (GCL) thickness [ Time Frame: Every 6 months from baseline to 3 years ]
    The results of the GCL thickness will be expressed in microns in different zones around the fovea region: temporal- superior, superior, nasal-superior, nasal inferior, inferior, temporal inferior and global.

Secondary Outcome Measures :
  1. • Visual Acuity [ Time Frame: Every 6 months from baseline to 3 years ]
    Will be expressed in decimal units

  2. • Color Discrimination [ Time Frame: Every 6 months from baseline to 3 years ]
    Will be expressed in decimal units.

  3. • Pupillometry [ Time Frame: Every 6 months from baseline to 3 years ]
    Measures will include pupil diameter (expressed in millimeters, in dark and light conditions and the amplitude and velocity of the pupillary response.

  4. • Videonystagmography [ Time Frame: Every 6 months from baseline to 3 years ]
    Saccadic velocity and amplitude (expressed in m/seg and degrees) will be measured.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We will select patients from our clinic and take advantage of the infrastructure used in the ongoing NIH-funded Natural History of Autonomic Disorders study ( NCT01799915), which prospectively follows patients with synucleinopathies with standardized neurological measures overtime.

Inclusion Criteria:

Subjects with PD, MSA and DLB that fulfill current diagnostic criteria.

  • Subjects with RBD that have polysomnography-confirmed diagnosis showing evidence of lack of muscle atonia and dream enacting behaviors during REM sleep.
  • Subjects with isolated autonomic failure (i.e., no motor deficits) that have evidence of neurogenic orthostatic hypotension and other features of autonomic failure without clinical evidence of cognitive impairment.
  • Control subjects with no history of neurological or ophthalmological disorders.

Exclusion Criteria:

  • Subjects with glaucoma, retinopathy, or significant media opacification (e.g., cataracts).
  • Subjects with a history of eye surgery or eye trauma
  • Inability to comply with the requirements of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02640339

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Contact: Jose M Martinez, MA 212 263 7225
Contact: Lucy J Norcliffe-Kaufmann, PhD. 212 263 7225

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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Anthony Carna, MBA    646-754-4601   
Principal Investigator: Horacio C Kaufmann, MD         
Sponsors and Collaborators
NYU Langone Health
Michael J. Fox Foundation for Parkinson's Research
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Principal Investigator: Horacio C Kaufmann, MD NYU Langone Health
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Responsible Party: NYU Langone Health Identifier: NCT02640339    
Other Study ID Numbers: 15-01391
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Brain Diseases
Parkinson Disease
Pure Autonomic Failure
Lewy Body Disease
REM Sleep Behavior Disorder
Disease Progression
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Disease Attributes
Pathologic Processes
Primary Dysautonomias
Autonomic Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
REM Sleep Parasomnias
Sleep Wake Disorders