Cholinergic Nicotinic Receptors and Cognition in PD (CHONI)

April 14, 2017 updated by: Martijn Muller, University of Michigan

[18F]Flubatine: a Novel Biomarker of Cholinergic a4ß2 Nicotinic Receptors and Cognition in Parkinson's Disease

Mild cognitive impairment and dementia are frequent non-motor complications of moderate to advanced Parkinson's disease. Brain positron emission tomography (PET) study findings confirm post-mortem evidence that cholinergic loss is related to cognitive impairment in Parkinson's disease. However, current cholinergic augmentation therapy is not always effective and it should only target those Parkinson's disease patients who have evidence of cholinergic system impairment. The objective of this study is to study the association of a particular subtype of cholinergic receptors, so-called nicotinic acetylcholine receptors, with cognition in Parkinson's disease using a novel PET marker of cholinergic system integrity.

Study Overview

Status

Completed

Conditions

Detailed Description

Parkinson's disease patients will undergo nicotinic acetylcholine receptor PET imaging with the radioligand [18F]flubatine and MRI on one day and extensive neuropsychological testing on another day. The degree of nicotinic receptor expression obtained with PET imaging will be correlated with the neuropsychology test results.

Positive [18F]flubatine PET findings in this study would establish nicotinic receptors as an important contributor to cognitive dysfunction in Parkinson's disease and could kindle pharmaceutical interest in pursuing these agents for Parkinson's disease applications.

We expect that lower nicotinic receptor expression is associated with impaired cognitive functioning in Parkinson's disease. In a personalized medicine approach the PET radioligand [18F]flubatine could serve as an important marker to identify those patients who are expected to benefit most from nicotinic receptor drug treatment.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

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

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System

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

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Primary care clinic
  • Community sample

Description

Inclusion criteria:

  • PD subjects (M/F, non-smoking, ≥ 50 years old, Hoehn & Yahr stages 1-4)
  • Normal control subjects (N=15, M/F, non-smoking, ≥ 50 years old)

Exclusion Criteria:

  • Active smoking, use of other tobacco products, or use of nicotinic drugs such as nicotine patches or varenicline.
  • Subjects with contra-indications to MR imaging, including pacemakers or claustrophobia.
  • Evidence of large vessel stroke or mass lesion on MRI.
  • Use of (anti-)cholinergic or neuroleptic drugs.
  • Dementia or severe cognitive impairment confirmed by clinical and detailed neuropsychological assessment precluding safe study participation, performing study procedures, or unable to follow directions by study personnel.
  • Evidence of atypical parkinsonism on neurological exam.
  • Subjects limited by participation in research procedures involving ionizing radiation.
  • Pregnancy (test within 48 hours of each PET session) or breastfeeding

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

Cohorts and Interventions

Group / Cohort
Parkinson's disease subjects
Normal control subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral cholinergic nicotinic receptor expression
Time Frame: Will be assessed during the neuroimaging study visit(s); typically 1 day
Cortical and sub-cortical [18F]flubatine binding
Will be assessed during the neuroimaging study visit(s); typically 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive performance
Time Frame: Will be assessed during the clinical visit(s); typically 1 day
Composite score of cognitive performance
Will be assessed during the clinical visit(s); typically 1 day

Collaborators and Investigators

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

Sponsor

University of Michigan

Collaborators

Michael J. Fox Foundation for Parkinson's Research

Investigators

  • Principal Investigator: Martijn T Muller, PhD, University of Michigan

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

February 1, 2014

Primary Completion (Actual)

December 30, 2016

Study Completion (Actual)

December 30, 2016

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

April 14, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00083054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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