Investigations of Dementia in Parkinson Disease

NCT ID: NCT02763683

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2030-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinsons

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Parkinsons Disease

Individuals with Parkinsons Disease

PiB and VAT

Intervention Type 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

Individuals without Parkinsons Disease

PiB and VAT

Intervention Type 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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joel S Perlmutter, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Washington University in St. Louis

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrea Slavik, RN, BSN

Role: CONTACT

314 273 8313

Susan Donovan

Role: CONTACT

314 362 6026

Facility Contacts

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Susan Donovan, BSN

Role: primary

314-362-6026

Kaleigh Oberndorfer

Role: backup

314 362 0420

Other Identifiers

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R01NS075321

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201512032

Identifier Type: -

Identifier Source: org_study_id

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