Imaging a Cholinergic Biomarker of Cognition in Parkinson's Disease

April 2, 2025 updated by: Chuan Huang, Stony Brook University
This is an imaging study designed to illuminate the function of the cholinergic system and its association with cognitive skills in people with Parkinson's disease. The hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. Participants will receive a PET and MRI scan along with a battery of neurocognitive tests at baseline and again at 18 months follow-up. Hormone levels will be measured at baseline.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is an imaging study designed to illuminate the functioning of the cholinergic system in people with Parkinson's disease. Some people with Parkinson's disease develop trouble with certain aspects of thinking such as memory. Studies have shown an association between a decline in thinking skills and dysfunction of the cholinergic system. This study will use the novel PET tracer [18F]VAT to provide more specific information about how the cholinergic system works by enabling direct measurement of cholinergic terminal density and projections. The hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. This is a longitudinal observational study that involves a screening visit and four study visits over the course of 18 months. The visits consist of neurocognitive assessments and imaging (MRI and PET scans) administered at baseline and at 18 months follow-up. Hormone levels will also be measured at baseline. This study is open to people with Parkinson's disease who have either normal cognition or mild cognitive impairment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People with Parkinson's disease who have normal cognition or mild cognitive impairment

Description

Inclusion Criteria:

  • Age 50-80
  • Diagnosis of Parkinson's disease
  • Ability to provide informed consent
  • Ability to speak English
  • Normal cognition or mild cognitive impairment
  • Willingness to go off parkinsonian medication for 12 hours prior to two of the study visits

Exclusion Criteria:

  • Contraindication for MRI
  • Abnormal clinical brain MRI, specifically with evidence of large-vessel stroke or mass lesion
  • History of stereotactic or ablative brain surgery
  • Pregnancy
  • Recent participation in other research studies involving radiation such that the annual research radiation dose would exceed FDA Limit if participating in this study
  • Prior brain injury (eg., TBI)
  • Baseline cognitive impairment due to genetic or developmental disorder
  • Active illicit drug use or alcohol abuse
  • Incapable of staying still for a 2-hour PET or MRI study
  • Use of CNS-penetrating medications affecting the cholinergic system, including cholinesterase inhibitors and anticholinergics, up to 60 days prior to study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cholinergic terminal density at baseline
Time Frame: Baseline
Measured by PET scan 18F[VAT] distribution volume
Baseline
Cholinergic terminal density change between baseline and 18-months follow-up
Time Frame: Baseline and 18 months follow-up
Measured by the difference in PET scan 18F[VAT] distribution volume at baseline and 18-months follow-up
Baseline and 18 months follow-up
Overall cognitive functioning at baseline
Time Frame: Baseline
As measured by the Montreal Cognitive Assessment (MoCA). The MoCA measures eight domains commonly affected by mild cognitive impairment. The one-page 30-point test includes assessments of short-term and delayed memory recall, visuospatial abilities, language, orientation to time and space, and executive functions including attention, concentration, and working memory. The MoCA has been shown to be sensitive to change over time. Scores on the MocA range from 0-30 with higher scores indicating better cognitive functioning.
Baseline
Change in overall cognitive functioning
Time Frame: Baseline and 18 Months
As measured by the difference between the Montreal Cognitive Assessment (MoCA) score at baseline and at 18-months follow-up.The MoCA measures eight domains commonly affected by mild cognitive impairment. The one-page 30-point test includes assessments of short-term and delayed memory recall, visuospatial abilities, language, orientation to time and space, and executive functions including attention, concentration, and working memory. The MoCA has been shown to be sensitive to change over time. Scores on the MocA range from 0-30 with higher scores indicating better cognitive functioning.
Baseline and 18 Months
Attention/working memory at baseline as measured by the Trail Making A Test
Time Frame: Baseline
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test A is 5 minutes.
Baseline
Attention/working memory change from baseline to 18-months follow-up as measured by the Trail Making A Test
Time Frame: 18 months
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test A is 5 minutes.
18 months
Attention/working memory at baseline as measured by the Symbol Digit Modalities Test (SDMT)
Time Frame: Baseline
Symbol Digit Modalities Test (SDMT) takes five minutes to complete and has demonstrated sensitivity in detecting changes in cognitive functioning over time.
Baseline
Attention/working memory change from baseline to 18-months follow-up as measured by the Symbol Digit Modalities Test
Time Frame: Baseline and 18- months follow-up
Symbol Digit Modalities Test (SDMT) takes five minutes to complete and has demonstrated sensitivity in detecting changes in cognitive functioning over time.
Baseline and 18- months follow-up
Executive function at baseline as measured by the Clock Drawing Test
Time Frame: Baseline
The Clock Drawing Test is a quick screening test for cognitive dysfunction secondary to a range of neurological disorders and takes less than 5 minutes to administer.
Baseline
Executive function change from baseline to 18-months follow-up as measured by the Clock Drawing Test
Time Frame: Baseline and 18-month follow-up
The Clock Drawing Test is a quick screening test for cognitive dysfunction secondary to a range of neurological disorders and takes less than 5 minutes to administer.
Baseline and 18-month follow-up
Executive function at baseline as measured by the Trail Making Test B
Time Frame: Baseline
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test B is 10 minutes.
Baseline
Executive function change from baseline to 18-months follow-up as measured by the Trail Making Test B
Time Frame: Baseline and 18-month follow-up
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test B is 10 minutes.
Baseline and 18-month follow-up
Language at baseline as measured by the Animal Naming Test
Time Frame: Baseline
The Animal Naming Test is a semantic fluency test that takes one minute to administer.
Baseline
Language change from baseline to 18-month follow-up as measured by the Animal Naming Test
Time Frame: Baseline and 18-months follow-up
The Animal Naming Test is a semantic fluency test that takes one minute to administer.
Baseline and 18-months follow-up
Language at baseline as measured by the Boston Naming Test
Time Frame: Baseline
The Boston Naming Test measures confrontational word retrieval and takes about 15 minutes to administer.
Baseline
Language change from baseline to 18-months follow-up as measured by the Boston Naming Test
Time Frame: Baseline and 18-months follow-up
The Boston Naming Test measures confrontational word retrieval and takes about 15 minutes to administer.
Baseline and 18-months follow-up
Language change between baseline and 18-month follow-up as measured by the Boston Naming Test
Time Frame: Baseline
The Boston Naming Test measures confrontational word retrieval and takes about 15 minutes to administer.
Baseline
Memory at baseline as measured by the Free and Cued Selective Reminding Test
Time Frame: Baseline
The Free and Cued Selective Reminding Test is an episodic memory test which assesses immediate and delayed free and cued-facilitated recall.
Baseline
Memory change from baseline to 18-months follow-up as measured by the Free and Cued Selective Reminding Test
Time Frame: Baseline and 18-months follow-up
The Free and Cued Selective Reminding Test is an episodic memory test which assesses immediate and delayed free and cued-facilitated recall.
Baseline and 18-months follow-up
Memory at baseline as measured by the Brief Visuospatial Memory Test-Revised Selective Reminding Test
Time Frame: Baseline
The Brief Visuospatial Memory Test-Revised is a brief measure of visuospatial memory that takes approximately 45 minutes to administer.
Baseline
Memory change from baseline to 18-months follow-up as measured by the Brief Visuospatial Memory Test-Revised
Time Frame: Baseline and 18-months follow-up
The Brief Visuospatial Memory Test-Revised is a brief measure of visuospatial memory that takes approximately 45 minutes to administer.
Baseline and 18-months follow-up
Memory change between baseline and 18-month follow-up
Time Frame: Baseline and 18-month follow-up
As measured by the change in Free and Cued Selective Reminding Test and the Brief Visuospatial Memory Test-Revised scores at baseline and at 18-months follow-up.
Baseline and 18-month follow-up
Visuospatial at baseline as measured by the Judgement of Line Orientation Test
Time Frame: Baseline
Judgement of Line Orientation measures visuospatial perception and takes less than 15 minutes to administer.
Baseline
Visuospatial change from baseline to 18-months follow-up as measured by the Judgement of Line Orientation Test
Time Frame: Baseline and 18-months follow-up
Judgement of Line Orientation measures visuospatial perception and takes less than 15 minutes to administer.
Baseline and 18-months follow-up
Visuospatial at baseline as measured by the Intersecting Pentagons Test
Time Frame: Baseline
Intersecting Pentagons is a measure of visuospatial sense that takes less than 5 minutes to administer.
Baseline
Visuospatial change from baseline to 18-months follow-up as measured by the Intersecting Pentagons Test
Time Frame: Baseline and 18-months follow-up
Intersecting Pentagons is a measure of visuospatial perception that takes less than 5 minutes to administer.
Baseline and 18-months follow-up
Estrogen levels in blood at baseline
Time Frame: Baseline
Estrogen levels (picograms of estradiol per milliliter of serum) will be measured via blood draw performed at baseline
Baseline
Progesterone levels in blood as baseline
Time Frame: Baseline
Progesterone levels (nanograms of progesterone per milliliter of serum) will be measured via blood draw at baseline
Baseline
Testosterone levels in blood at baseline
Time Frame: Baseline
Levels of free testosterone (picograms testosterone per milliliter serum) and total testosterone (nanograms testosterone/deciliter serum) will be measured via blood draw performed at the baseline visit.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cholinergic terminal binding potential at baseline
Time Frame: Baseline
Measured by PFC [18F]VAT VT and BPND
Baseline
Cholinergic terminal binding potential change between baseline and 18-months follow-up
Time Frame: Baseline and 18-month follow-up
Measured by PFC [18F]VAT VT and BPND
Baseline and 18-month follow-up
MRI Fractional anisotropy (FA) Values at baseline
Time Frame: Baseline
As measured by fMRI at baseline
Baseline
Change in MRI Fractional anisotropy (FA) Values from baseline to 18-months follow-up
Time Frame: Baseline and 18-months follow-up
As measured by fMRI at baseline and 18-months follow-up
Baseline and 18-months follow-up
MRI Resting-state functional connectivity at baseline
Time Frame: Baseline
As measured by fMRI
Baseline
MRI Resting-state functional connectivity change between baseline and 18-months follow-up
Time Frame: Baseline and 18-months follow-up
As measured by fMRI
Baseline and 18-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stony Brook University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Parkinson's Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chuan Huang, PhD, Stony Brook Medical Center
  • Principal Investigator: Carine Maurer, PhD, Stony Brook Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-00669

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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