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Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation (LRRK2)

8 juni 2026 bijgewerkt door: Prabesh Kanel, University of Michigan
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.

Studie Overzicht

Toestand

Werving

Gedetailleerde beschrijving

LRRK2 mutations are among the most common genetic risk factors for Parkinson's Disease (PD), accounting for ~1% to 36% of familial cases depending on the ancestry, and a significant fraction of sporadic cases. These mutations are not fully penetrant, with 17-85% of carriers eventually developing PD. Among LRRK2-PD patients, clinical features manifest differently compared to idiopathic PD (iPD). LRRK2-PD patients often experience milder progression, with fewer non-motor symptoms and relatively preserved cognition, but higher likelihood of postural instability and gait difficulties (PIGD). This complex profile likely reflects the pleiotropic nature of LRRK2 effects, with mutations causing pathological increases in kinase activity and hyperphosphorylation of downstream targets. A comprehensive understanding of the protective and harmful changes induced by LRRK2 mutations remains a significant research gap.

While PD has traditionally been viewed as primarily a dopaminergic disorder, it is increasingly recognized as a multi-system condition involving other neuromodulatory systems, particularly cholinergic systems. Loss of cholinergic systems integrity is linked to dopamine-refractory symptoms, including morbid gait and cognitive impairments. Recent studies, however, demonstrate that subsets of both newly diagnosed and established PD patients exhibit upregulation of the vesicular acetylcholine transporter (VAChT), associated with preserved cognitive function, in both cross-sectional and longitudinal analyses.

A comprehensive, whole-brain investigation using the specific 18F-fluoroethoxybenzovesamicol ([18F]FEOBV) radioligand will help us better understand the nuanced whole-brain system changes in cholinergic nerve terminal integrity in LRRK2-PD compared to iPD. Our primary recruitment efforts will focus on the University of Michigan's Movement Disorder clinics, allowing us to connect with individuals diagnosed with PD who have the LRRK2 mutation. Additionally, we will work closely with PDGENEration and their sites such as Cleveland and Columbus. This collaboration will provide access to a larger pool of individuals with LRRK2 mutations, improving our ability to recruit participants for our study and ensuring a thorough investigation. We will identify regional cholinergic system alterations in PD with LRRK2 mutations. This would facilitate research on understanding the pathogenic basis for cholinergic activity alterations in iPD as well. Cholinergic systems offer multiple potential targets for pharmacologic and non-invasive neurostimulation interventions. Identification of distinctive cholinergic systems abnormalities in LRRK2-PD would provide new targets for potential therapies, initiating new approaches to experimental therapeutics in PD with LRRK2 mutations and informed by novel insights into PD pathomechanisms.

Aim 1a: To assess in vivo comprehensive, whole-brain expression and activity of cholinergic nerve terminals of LRRK2-PD patients relative to iPD patients using the [18F]FEOBV vesicular acetylcholine transporter (VAChT) radioligand.

Aim 1b: To correlate in vivo striatal and extra-striatal [18F]FEOBV regional binding with cognitive and motor assessments (esp. PIGD symptoms) in LRRK2-PD and iPD.

Aim 2a: To examine differences in striatal and extra-striatal dopamine terminal density between LRRK2-PD and iPD using the complementary PET tracer N-(3-iodoprop-2E-enyl)-2β-carbomethoxy-3β-(4-methyl-phenyl)nortropane ([¹¹C]PE2i).

Aim 2b: To investigate the association between dopaminergic function, cognition, and PIGD symptoms

Studietype

Observationeel

Inschrijving (Geschat)

15

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48106
        • Werving
        • University of Michigan
        • Hoofdonderzoeker:
          • Prabesh Kanel, PhD
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Individuals with Parkinson's disease and the LRRK2 genetic mutation.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cholinergic Differences Between leucine-rich repeat kinase 2 (LRRK2) Parkinson's disease (PD) and Idiopathic/non-LRRK2 PD (iPD)
Tijdsspanne: Baseline
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.
Baseline
Dopaminergic Differences Between LRRK2-PD and iPD
Tijdsspanne: Baseline
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.
Baseline
Association of Cholinergic Data With Cognition in LRRK2-PD
Tijdsspanne: Baseline
Association of the global average cholinergic uptake (represented by VAChT uptake) with the global average cognitive z-score of individuals with LRRK2-PD.
Baseline
Association of Cholinergic Data With Postural Instability and Gait Difficulties (PIGD) in LRRK2-PD
Tijdsspanne: Baseline
Association of the global average cholinergic uptake (represented by VAChT uptake) with the global average PIGD score of individuals with LRRK2-PD.
Baseline
Association of Dopaminergic Data With Cognition in LRRK2-PD
Tijdsspanne: Baseline
Association of the global average dopaminergic uptake (represented by DAT uptake) with the global average cognitive z-score of individuals with LRRK2-PD.
Baseline
Association of Dopaminergic Data With PIGD in LRRK2-PD
Tijdsspanne: Baseline
Association of the global average dopaminergic uptake (represented by DAT uptake) with the global average PIGD score of individuals with LRRK2-PD.
Baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Prabesh Kanel, PhD, University of Michigan

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 september 2025

Primaire voltooiing (Geschat)

17 september 2026

Studie voltooiing (Geschat)

17 september 2026

Studieregistratiedata

Eerst ingediend

13 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juni 2026

Eerst geplaatst (Werkelijk)

11 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

8 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified individual participant data (imaging data, clinical assessments, and neuropsychological test results) may be shared with other researchers. Data will be shared with the study sponsor (Michael J. Fox Foundation) for the purposes of contributing to Parkinson's Progression Markers Initiative (PPMI) repository. Data will be available through PPMI on a case-by-case basis upon reasonable request after the completion of the study.

IPD-tijdsbestek voor delen

Data will be made available within 12 months of primary study completion (by September 2027) and will remain available for a minimum of 5 years.

IPD-toegangscriteria voor delen

Researchers seeking access to de-identified data must submit a brief research proposal to the principal investigator and execute a data use agreement in accordance with University of Michigan institutional policies or request access to the data via PPMI.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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