Investigations of Dementia in Parkinson Disease
ConditionParkinsons
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorWashington University School of Medicine
About this trial
The purpose of this study is to use a brain imaging method called Pittsburgh B (PIB) Positron Emission Tomography (PET) and Vesicular Cholinergic Transport (VAT) PET to determine dementia subtypes in patients with Parkinson disease (PD). The ultimate goal of this project is to be able to identify individuals with PD who are at risk of developing dementia, and to distinguish the underlying cause of dementia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
PD patients must exhibit three of the following cardinal signs: rest tremor, rigidity, bradykinesia, or postural instability; or two of these features with one of the first three displaying asymmetry.
Disqualifiers
history of head trauma, major neurological or psychiatric diseases other than Parkinson disease and dementia, e.g. stroke, multiple sclerosis, depression or schizophrenia.
severe systemic diseases.
inability to lie still for 90 minutes.
metallic implants, pacemakers, or any other contraindication to MRI.
Trial population
Participants with and without Parkinson disease will be recruited from the Movement Disorders Center at Washington University, the St. Louis metro area, and throughout the midwest region.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
PiB and VAT
RadiationThere is no intervention for this study. The PiB and VAT are used during the PET procedures to help to identify any excessive abnormal proteins in the brain.
Treatment groups
320 Participants
are divided into 2 treatment groupsGroup A: Parkinsons Disease1 intervention
Group B: Healthy Controls1 intervention
Trial outcomes
Primary outcomes
1
Investigations of Dementia in Parkinsons Disease
The investigators will perform memory/thinking testing, Lumbar puncture (LP), Magnetic Resonance Imaging (MRI) and (PET) scans to help to determine the cause(s) of memory and thinking in Parkinson Disease. The memory and thinking testing by phone on average at 1.5 years through study completion and then in person on average at 3 years through study completion, this will help monitor if there is any decline in memory and thinking. The Lumbar Puncture is done on willing participants on average at 3 years through study completion to assess for any abnormal proteins and correlate these with any changes in memory and thinking. The MRI is done on average at 3 years through study completion for any abnormal signs or changes in regards to dementia at 3 years. The (PiB) \& (VAT) PET scans will be performed on average at 3 years through study completion, which will be analyzed to assess for changes in regards to abnormal proteins and signs of dementia.
Time frame
2030Sponsors and contacts
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Washington University School of Medicine
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov