Cholinergic Nicotinic Receptors and Cognition in PD

NCT02076295 | Completed

• 1 other identifier: HUM00083054
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Cognition; Cholinergic nicotinic receptors; Positron Emission Tomography

Outcome Measures

Primary Outcomes (1)

• Cerebral cholinergic nicotinic receptor expression

  Cortical and sub-cortical \[18F\]flubatine binding

  Will be assessed during the neuroimaging study visit(s); typically 1 day

Secondary Outcomes (1)

• Cognitive performance

  Will be assessed during the clinical visit(s); typically 1 day

Study Arms (2)

Parkinson's disease subjects

Normal control subjects

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Primary care clinic * Community sample

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples to collect DNA

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Martijn T Muller, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 3, 2014
• Study Start: February 1, 2014
• Primary Completion: December 30, 2016
• Study Completion: December 30, 2016
• Last Updated: April 17, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)