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Investigations of Dementia in Parkinson Disease (PIB)

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ClinicalTrials.gov Identifier: NCT02763683
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment
Parkinsons Radiation: PiB and VAT

Detailed Description:
The purpose of this study is to use a brain imaging method called PIB PET and 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. The investigators will be including both PD and normal subjects in this study. This a long term study and we are considering including a total of 320 participants in this protocol.

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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Investigations of Dementia in Parkinson Disease
Study Start Date : June 2016
Estimated Primary Completion Date : March 2030
Estimated Study Completion Date : March 2030

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parkinsons Disease
Individuals with Parkinsons Disease
Radiation: PiB and VAT
There 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.

Healthy Controls
Individuals without Parkinsons Disease
Radiation: PiB and VAT
There 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.




Primary Outcome Measures :
  1. Investigations of Dementia in Parkinsons Disease [ Time Frame: 2030 ]

    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 6 years through study completion, which will be analyzed to assess for changes in regards to abnormal proteins and signs of dementia.



Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study 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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • refusal to consent to brain donation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763683


Contacts
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Contact: Kelly McVey, BSN 314-362-4154 mcveyk@wustl.edu
Contact: Joel S Perlmutter, MD 314-362-6026 perlmutterjoel@wustl.edu

Locations
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United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kelly McVey, BSN    314-362-4154    mcveyk@wustl.edu   
Contact: Susan Donovan    314 362 6026    donovan@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Joel S Perlmutter, MD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02763683     History of Changes
Other Study ID Numbers: 201512032
R01NS075321 ( U.S. NIH Grant/Contract )
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified data that has been published will be shared upon request.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: after publication of the results
Access Criteria: request from a legitimate investigator with a proposal sent to and approved by Joel S Perlmutter at Washington University.

Keywords provided by Washington University School of Medicine:
Parkinsons Disease
PET Imaging
PIB
VAT
Dementia

Additional relevant MeSH terms:
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Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders