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Investigations of Dementia in Parkinson Disease (PIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02763683
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : May 13, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date April 28, 2016
First Posted Date May 5, 2016
Last Update Posted Date May 13, 2021
Study Start Date June 2016
Estimated Primary Completion Date March 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2020)
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.
Original Primary Outcome Measures
 (submitted: May 3, 2016)
Investigations of Dementia in Parkinsons Disease [ Time Frame: 2030 ]
The investigators will perform memory/thinking testing, LP, MRI and PET scans to help to determine the cause(s) of memory and thinking in Parkinson Disease. The memory and thinking testing which will be performed 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 to determine if there is any decline in memory and thinking. The Lumbar Puncture will be performed on willing participants on average at 3 years through study completion to assess for any abnormal proteins and thus assess the number of abnormal proteins with any changes in memory and thinking. The MRI will be performed on average at 3 years through study completion for any abnormal signs or changes in regards to dementia at 3 years. The PiB and VAT PET scans will be performed on average at 6 years through study completion, which will be analyzed to assess for changes in regards to abnormal proteins and signs of dementia.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigations of Dementia in Parkinson Disease
Official Title Investigations of Dementia in Parkinson Disease
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
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.
Condition 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.
Study Groups/Cohorts
  • Parkinsons Disease
    Individuals with Parkinsons Disease
    Intervention: Radiation: PiB and VAT
  • Healthy Controls
    Individuals without Parkinsons Disease
    Intervention: Radiation: PiB and VAT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 3, 2016)
320
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2030
Estimated Primary Completion Date March 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Andrea Slavik, RN, BSN 3145807553 andreaslavik@wustl.edu
Contact: Enid McIntosh 314-362-6026 enidmcintosh@wustl.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02763683
Other Study ID Numbers 201512032
R01NS075321 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: de-identified data that has been published will be shared upon request.
Supporting Materials: Informed Consent Form (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.
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators
  • National Institutes of Health (NIH)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institute on Aging (NIA)
Investigators
Principal Investigator: Joel S Perlmutter, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date May 2021