Investigations of Dementia in Parkinson Disease (PIB)

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 Overview

• Status: Recruiting
• Conditions: Parkinsons
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Estimated): 320

Contacts and Locations

• Study Contact: Name: Kaleigh Oberndorfer, RN, BSN; Phone Number: 314 3620420; Email: kaleigh@wustl.edu
• Study Contact Backup: Name: Susan Donovan; Phone Number: 314 362 6026; Email: donovan@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University in St. Louis
      • Contact: Susan Donovan, BSN; Phone Number: 314-362-6026; Email: donovan@wustl.edu
      • Contact: Kaleigh Oberndorfer; Phone Number: 314 362 0420; Email: kaleigh@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2030

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Joel S Perlmutter, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimated): May 5, 2016

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: PET Imaging; Dementia; Parkinsons Disease; PIB; VAT
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Dementia
• Other Study ID Numbers: 201512032; R01NS075321 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified data that has been published will be shared upon request.
• IPD Sharing Time Frame: after publication of the results
• IPD Sharing Access Criteria: request from a legitimate investigator with a proposal sent to and approved by Joel S Perlmutter at Washington University.
• IPD Sharing Supporting Information Type: ICF