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Diagnostic Test for Lewy Body Dementia and Related Diseases

Start: January 4, 2021
End: December 2022
Enrollment: 500

What Is This Study About?

This study will test a diagnostic test, called Synuclein-One, for detecting Lewy body dementia, Parkinson's disease, and other synucleinopathies through a skin sample. Synucleinopathies are diseases in which there is abnormal clumping of a protein, alpha-synuclein, in neurons and other cells. Researchers will also determine if the test can distinguish between different synucleinopathies by comparing test results from healthy volunteers and people diagnosed with Lewy body dementia, Parkinson's disease, multiple system atrophy, or pure autonomic failure. In a single study visit, participants will provide their medical history, receive a physical and neurological exam, complete questionnaires, and provide a small sample of skin.

Do I Qualify To Participate in This Study?

Minimum Age: 40 Years

Maximum Age: 99 Years

Must have:

Participants With Neurodegenerative Disease:

  • Individuals with a diagnosis of Lewy body dementia, Parkinson's disease, multiple system atrophy, or pure autonomic failure

Healthy Volunteers:

  • No history or symptoms of neurological disease

Must NOT have:

All Participants:

  • Evidence of severe vascular disease
  • Current coronary artery or cerebrovascular disease
  • Current smoker or alcohol abuse
  • History of allergic reaction to local anesthesia
  • Use of blood thinners (aspirin or Plavix alone is allowed)
  • Significantly impaired wound healing or history of keloid formation

Participants With Neurodegenerative Disease:

  • History or diagnosis of other conditions or issues that could be an underlying cause of neurological symptoms, such as recent encephalitis, Alzheimer's disease, Whipple disease, toxin exposure, or repeated head injury

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 
Study Contact
Jade Stohl
Todd Levine, MD

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Arizona
MD First Research
Chandler, AZ 85286
Recruiting
Ashely Mitchell
CND Life Sciences
Phoenix, AZ 85018
Recruiting
Jade Stohl
Movement Disorders Center of Arizona
Scottsdale, AZ 85258
Recruiting
Susan Ortega
California
The Neuro Center
Carlsbad, CA 92011
Recruiting
Estela Soto
Providence St. John's Health
Santa Monica, CA 90404
Recruiting
Mini Gill
Colorado
Rocky Mountain Movement Disorders Center, PC
Englewood, CO 80113
Recruiting
Janell DeGiorgio
Florida
Aventura Neurology
Aventura, FL 33180
Recruiting
Jose Macias
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, FL 33486
Recruiting
Randi Provenzano
UF College of Medicine
Gainesville, FL 32608
Recruiting
Stephan Alvarex
Parkinson's Disease Treatment Center SWFL
Port Charlotte, FL 33980
Recruiting
Rachel Klasmeyer
Illinois
NorthShore University Health System
Evanston, IL 60201
Recruiting
Lisette Garduno
Massachusetts
Boston Medical Center
Boston, MA 02118
Recruiting
Raymond James
Beth Israel Lahey Health
Boston, MA 02215
Recruiting
Tanya Fennell
Minnesota
Mayo Clinic
Rochester, MN 55905
Recruiting
Jennifer Anderson
New York
NYU Medical Center
New York, NY 10016
Recruiting
Jose Martinez
SouthShore Neurologic
Patchogue, NY 11772
Recruiting
Kaitlyn Jaenicke
North Carolina
Duke University Medical Center
Durham, NC 27710
Recruiting
Karen White
Oregon
Providence Brain & Spine Institute
Portland, OR 97225
Recruiting
Eliza Chow
Tennessee
Vanderbilt University Medical Center
Nashville, TN 37232
Recruiting
Katie Hay
Texas
UTSouthwestern
Dallas, TX 75390
Recruiting
Amy Conger
Texas Movement Disorders Specialists
Georgetown, TX 78628
Recruiting
Wendy White
Washington
Evergreen Health
Kirkland, WA 98034
Recruiting
Gowri Rajendran
Swedish Neuroscience Research
Seattle, WA 98122
Recruiting
Katie Gelinas

Who Sponsors This Study?

Lead: CND Life Sciences

Source: ClinicalTrials.gov ID: NCT04700722