Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorUniversity of Michigan
About this trial
This study explores how a specific genetic mutation of leucine-rich repeat kinase 2 (LRRK2) affects individuals with Parkinson's disease (PD), comparing those with the mutation to others with Parkinson's disease and without the mutation (iPD). Participants will complete positron emission tomography (PET) and magnetic resonance imaging (MRI) brain imaging, cognitive tests, motor tests, sensory tests, and questionnaires. The aims of this study are to compare brain chemicals in LRRK2 PD patients with iPD patients and to correlate brain chemicals with motor and cognitive tests in LRRK2 PD and iPD patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or Female, age 45 years and over.
Diagnosis of PD based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria (Hughes et al., 1992).
Presence of LRRK2 mutation as confirmed by referral from UM Movement Disorders clinic, medical record review, or participation in the PDGENEration study.
Disqualifiers
Evidence of atypical parkinsonism.
Contra-indications to MR imaging including but not limited to pacemakers, aneurysm clips, intraocular metal, cochlear implant, or severe claustrophobia.
Evidence of large vessel stroke or mass lesion on MRI.
Regular use of typical anti-cholinergic drugs or cholinesterase inhibitors.
Trial population
Individuals with Parkinson's disease and the LRRK2 genetic mutation.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
15 Participants
are grouped into 2 trial groupsGroup A: LRRK2
Group B: iPD
Trial outcomes
Primary outcomes
1
Cholinergic Differences Between leucine-rich repeat kinase 2 (LRRK2) Parkinson's disease (PD) and Idiopathic/non-LRRK2 PD (iPD)
The cholinergic system changes for people with PD. It is anticipated that LRRK2-PD will demonstrate different cholinergic expression compared to iPD. 18F-fluoroethoxybenzovesamicol (\[18F\]FEOBV) PET scans will be used to measure Vesicular acetylcholine transporter (VAChT). Higher levels of VAChT binding indicate higher levels of acetylcholine in the brain. Lower levels of VAChT binding indicate lower levels of acetylcholine in the brain. VAChT levels will be compared across brain regions for LRRK2 vs iPD.
Time frame
Baseline2
Dopaminergic Differences Between LRRK2-PD and iPD
The dopaminergic system changes for people with PD. It is anticipated that LRRK2-PD will demonstrate different dopaminergic expression compared to iPD. N-(3-iodoprop-2E-enyl)-2β-carbomethoxy-3β-(4-methyl-phenyl)nortropane (\[¹¹C\]PE2i) PET scans will be used to measure dopamine transporter (DAT). Higher levels of DAT binding indicate higher levels of dopamine in the brain. Lower levels of DAT binding indicate lower levels of dopamine in the brain. DAT levels will be compared across brain regions for LRRK2 vs iPD.
Time frame
Baseline3
Association of Cholinergic Data With Cognition in LRRK2-PD
Association of the global average cholinergic uptake (represented by VAChT uptake) with the global average cognitive z-score of individuals with LRRK2-PD.
Time frame
Baseline4
Association of Cholinergic Data With Postural Instability and Gait Difficulties (PIGD) in LRRK2-PD
Association of the global average cholinergic uptake (represented by VAChT uptake) with the global average PIGD score of individuals with LRRK2-PD.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Michael J. Fox Foundation for Parkinson's Research
Collaborator
Source ClinicalTrials.gov