Investigations of Dementia in Parkinson Disease

Parkinsons Clinical Trial

— PIB  

Official title:

Investigations of Dementia in Parkinson Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02763683
• Other study ID #: 201512032
• Secondary ID: R01NS075321
• Status: Recruiting
• Start date: June 2016
• Est. completion date: March 2030

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: Kaleigh Oberndorfer, RN, BSN
• Phone: 314 3620420
• Email: kaleigh[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: March 2030
• Est. primary completion date: March 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Parkinson Disease
• Parkinsons

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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