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Longitudinal Natural History Protocol for PRKN- and PINK1-Linked PD

NCT07613112 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2026-05-29

No results posted yet for this study

Summary

Background:

Parkinson s disease is a neurologic disorder that affects movement. Its cause is unknown, and it usually begins later in life. Gene changes (PRKN and PINK1) can also cause rare types of Parkinson s disease that start at a young age. Researchers want to conduct a natural history study to learn more about how genes play a role in Parkinson s disease.

Objective:

To collect data and biological samples from people with different types of Parkinson s disease.

Eligibility:

People aged 18 to 80 years with either Parkinson s disease or PRKN- and PINK1-linked Parkinson s disease. Healthy volunteers are also needed.

Design:

Participants will have 6 clinic visits over 5 years. Each visit may take 1 to 3 days.

During each visit:

Participants will have a physical exam. The exam will be videotaped.

They will answer questions about their movement, thinking, mood, and sense of smell. The extent of any symptoms of Parkinson s disease will be evaluated: Participants movements may be assessed with a finger tapping test. They may be asked to scratch and sniff different scented strips to identify odors.

They will wear motion sensors on their arms, legs, chest, and back at the clinic. They will wear motion sensor devices on their wrists at home for 1 week.

Blood and urine samples will be collected.

Other tests are optional:

Magnetic resonance imaging (MRI) scan of the brain. Participants will lie on a table that slides into a tube.

Lumbar puncture (spinal tap). A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.

Muscle biopsy. A small sample of tissue will be taken from the leg.

Conditions

  • PARKINSON DIS

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Debra J Ehrlich, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2036-05-30
Completion
2036-05-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07613112 on ClinicalTrials.gov