Clinical research study of a gene therapy for patients with Parkinson's Disease (RESTORE-1)

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Please answer a few questions to see if you may qualify.
Have questions? Please contact the study coordinator Olga, Clinical Research Coordinator at okishchenko@ucdavis.edu or call (916) 703-9173
By clicking "Next", you're consenting to participate in this questionnaire. There are no right or wrong answers and everything you enter is confidential.
  1. *1. Have you been diagnosed with Parkinson's Disease for at least 4 years?
  2. *2. Are you between 40 - 75 years of age?
  3. *3. Are you willing to travel to UCSF for a surgical procedure (infusion of study therapy)?
  4. *4. Have you not had Deep Brain Stimulation (DBS) and are you willing to defer any neurological surgery?
  5. *5. Have you not had a major depression episode or suicide attempt within the last 5 years?
  6. *6. Have you had any problems with substance abuse (including tetrahydrocannabinol) within the last 2 years?
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"Please consider this clinical research study evaluating the safety and efficacy of an investigational gene therapy in Parkinson's Disease"
Age: 40 Years to 75 Years (inclusive)
Gender:
Any
Healthy Volunteers: No
Keywords: Parkinson's Disease
Type: Phase 2 study, Gene therapy
Target:
4 Participants
Investigator:
Description
This study will test the safety and efficacy of an investigational gene therapy in people with Parkinson's Disease. The purpose is to determine if the gene therapy is better than placebo at improving PD motor symptoms.

The gene therapy introduces a gene with instructions for making an enzyme that plays an important role in the production of dopamine in the brain. The therapy is injected in the brain during a surgical procedure.

This study is conducted at the UC Davis Department of Neurology. Surgery and some imaging will be performed at San Francisco VA. You will receive the investigational therapy and study evaluations at no cost. Additionally, transportation, hotel stay, and parking to and from visits is available free of charge. You will also receive additional compensation for your participation in study visits.
This study requires
  • Multiple visits over about 1 year at the UC Davis Department of Neurology
  • Surgical procedure and F-DOPA PET imaging at San Francisco VA
Who can participate
  • Have a diagnosis of Parkinson's Disease for at least 4 years
  • Be 40 to 75 years of age (inclusive)
  • Willing to travel to San Francisco VA for the surgical procedure (infusion of study therapy)
  • Have not had Deep Brain Stimulation (DBS) and willing to defer any neurological surgery
  • No history of major depression or suicide attempts within the last 5 years
  • No history of substance abuse within 2 years of screening
Benefits and risks of participating
Possible benefits may include improvement of Parkinson's Disease symptoms and responsiveness to medication. You are not guaranteed any benefit by participating in the research study. Risks include problems associated with the surgical procedure or the therapy.
Compensation
You will receive the investigational therapy and study evaluations at no cost. Additionally, transportation, hotel stay, and parking to and from visits is available free of charge. You will also receive additional compensation for your participation in study visits.
Resources
Location
UC Davis Department of Neurology
3160 Folsom Boulevard
Sacramento, CA 95816
Contact
Olga, Clinical Research Coordinator
Research Topic
Conditions:
  • Parkinson's Disease

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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