Investigations of Dementia in Parkinson Disease

NCT02763683 | Recruiting

• 2 other identifiers: 201512032R01NS075321
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinsons

Keywords

Parkinsons Disease; PET Imaging; PIB; VAT; Dementia

Outcome Measures

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.

  2030

Study Arms (2)

Parkinsons Disease

Individuals with Parkinsons Disease

Radiation: PiB and VAT

Healthy Controls

Individuals without Parkinsons Disease

Radiation: PiB and VAT

Interventions

PiB and VAT RADIATION

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; Parkinsons Disease

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Parkinson Disease; Dementia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Joel S Perlmutter, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Slavik, RN, BSN

CONTACT

314 273 8313; andreaslavik@wustl.edu

Susan Donovan

CONTACT

314 362 6026; donovan@wustl.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 5, 2016
• Study Start: June 1, 2016
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)