Investigations of Dementia in Parkinson Disease

Recruiting

• Conditions: Parkinsons
• Interventions: Radiation: PiB and VAT

• Registration Number: NCT02763683
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Study Start: 2016-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-06
• Primary Completion: 2030-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinsons Disease	PiB and VAT	Individuals with Parkinsons Disease
Healthy Controls	PiB and VAT	Individuals without Parkinsons Disease

Primary Outcome Measures

Name	Time	Method
Investigations of Dementia in Parkinsons Disease	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 3 years through study completion, which will be analyzed to assess for changes in regards to abnormal proteins and signs of dementia.

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States