Saint Louis, Missouri 63110

  • Parkinsons

Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

201512032


NCT ID:

NCT02763683


Secondary ID:

R01NS075321


Study Acronym:

PIB


Brief Title:

Investigations of Dementia in Parkinson Disease


Official Title:

Investigations of Dementia in Parkinson Disease


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

50 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Washington University School of Medicine


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

320


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Joel S Perlmutter, MD
Principal Investigator
Washington University School of Medicine
Primary Contact:Andrea Slavik, RN, BSN
3145807553
andreaslavik@wustl.edu
Backup Contact:Enid McIntosh
314-362-6026
enidmcintosh@wustl.edu

Study Dates

Start Date:June 2016
Completion Date:March 2030
Completion Type:Anticipated
Primary Completion Date:March 2030
Primary Completion Type:Anticipated
Verification Date:May 2021
Last Changed Date:May 12, 2021
First Received Date:April 28, 2016

Study Outcomes

Outcome Type:Primary Outcome
Measure:Investigations of Dementia in Parkinsons Disease
Time Frame:2030
Safety Issues:False
Description: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 aver

Study Interventions

Intervention Type:Radiation
Name:PiB and VAT
Description: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.
Arm Name:Healthy Controls

Study Arms

Study Arm Type:Other
Arm Name:Healthy Controls
Description:Individuals without Parkinsons Disease
Study Arm Type:Other
Arm Name:Parkinsons Disease
Description:Individuals with Parkinsons Disease

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Washington University School of Medicine
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Samples and Retentions

Sample Retention:Samples With DNA
Description: whole blood
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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

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