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NCT Number: NCT02763683

Investigations of Dementia in Parkinson Disease

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.

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Key information

Conditions

Parkinsons Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Investigations of Dementia in Parkinsons Disease

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Slavik, RN, BSN

CONTACT

[email protected]

314 273 8313

Hailee Domash

CONTACT

[email protected]

314 362 6026

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Registry information

Acronym: PIB

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
May 5, 2016
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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