Recruiting

LRRK2 vs. iPD

Sponsor:

University of Michigan

Code:

NCT07642908

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Parkinson Disease

Study ID

NCT07642908

Start date

Sep 18, 2025

Status verified date

Jun, 2026

Completion date

Sep 17, 2026

Anticipated

Primary completion date

Sep 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or Female, age 45 years and over.
2. Diagnosis of PD based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria (Hughes et al., 1992).
3. Presence of LRRK2 mutation as confirmed by referral from UM Movement Disorders clinic, medical record review, or participation in the PDGENEration study.

Exclusion Criteria:

1. Evidence of atypical parkinsonism.
2. Contra-indications to MR imaging including but not limited to pacemakers, aneurysm clips, intraocular metal, cochlear implant, or severe claustrophobia.
3. Evidence of large vessel stroke or mass lesion on MRI.
4. Regular use of typical anti-cholinergic drugs or cholinesterase inhibitors.
5. History of deep brain stimulation surgery.
6. Pregnant or nursing.
7. Suicidal ideation, as indicated by a response of 2 or 3 on question 9 of the Beck Depression Inventory.
8. Cognitive impairment that results in the inability to give consent, as demonstrated by the Decision Making Capacity Tool.
9. Any other condition or criterion that would preclude safe and meaningful participation in the study.

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

LRRK2

Individuals with PD and LRRK2 genetic mutation.

iPD

Individuals with PD and without LRRK2 genetic mutation (Pre-existing cohorts, not recruiting).

Primary outcome measure

  • Cholinergic Differences Between leucine-rich repeat kinase 2 (LRRK2) Parkinson's disease (PD) and Idiopathic/non-LRRK2 PD (iPD) [ Time Frame: Baseline ]
  • Dopaminergic Differences Between LRRK2-PD and iPD [ Time Frame: Baseline ]
  • Association of Cholinergic Data With Cognition in LRRK2-PD [ Time Frame: Baseline ]
  • Association of Cholinergic Data With Postural Instability and Gait Difficulties (PIGD) in LRRK2-PD [ Time Frame: Baseline ]
  • Association of Dopaminergic Data With Cognition in LRRK2-PD [ Time Frame: Baseline ]
  • Association of Dopaminergic Data With PIGD in LRRK2-PD [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Principal Investigator:

Prabesh Kanel, PhD

More Information

Sponsor

University of Michigan

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Parkinson's Disease
  • LRRK
  • LRRK2
  • functional neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-06-11.