Sponsor study identifier
Secondary identifiers
observational
70
1 country
1
Study Start
November 3, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
May 30, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 30, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 28, 2026
Actual (reported)May 29, 2026
Actual (reported)November 3, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 30, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 30, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Estimation of progression of motor symptoms across cohorts
Measured by annual change in MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
When final patient completes their last visit
Annual change in MDS-UPDRS parts I, II, IV
When final patient completes their last visit
Annual change in Montreal Cognitive Assessment (MoCA)
When final patient completes their last visit
Annual change in Timed up and go (TUG)
When final patient completes their last visit
Annual change in 10-meter walk
When final patient completes their last visit
Annual change in 360 degree turn
When final patient completes their last visit
Lack of current or clinically significant neurological disorder (based on investigator determination).
participants who carry one or two pathogenic variants in PRKN and/or PINK1 but do not have a diagnosis of PD
PD participants with idiopathic PD
Monoallelic: PD participants carrying one pathogenic mono-allelic variant in PRKN and/or PINK1
Biallelic: PD participants carrying two pathogenic variants in PRKN or PINK1
There will be a total of up to 50 male or female participants 18- 80 years of age and older in 5 cohorts. Target number of completers for each cohort are listed below: - PD mito-biallelic (PD participants carrying two pathogenic variants in PRKN or PINK1): up to 15 - PD mito-monoallelic (PD participants carrying one pathogenic mono-allelic variant in PRKN and/or PINK1): up to 10 - PD idiopathic: up to 5 - Non-manifesting mito (participants who carry one or two pathogenic variants in PRKN and/or PINK1 but do not have a diagnosis of PD): up to 15 - Healthy controls: up to 5
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Debra J Ehrlich, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
First Submitted
May 28, 2026
First Posted
May 29, 2026
Study Start
November 3, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
May 30, 2036
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 30, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10-09
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Source: ClinicalTrials.gov.
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