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

8. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Anslået)

15

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • Rekruttering
        • University of Michigan
        • Ledende efterforsker:
          • Prabesh Kanel, PhD
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cholinergic Differences Between leucine-rich repeat kinase 2 (LRRK2) Parkinson's disease (PD) and Idiopathic/non-LRRK2 PD (iPD)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
Association of the global average dopaminergic uptake (represented by DAT uptake) with the global average PIGD score of individuals with LRRK2-PD.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Prabesh Kanel, PhD, University of Michigan

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. september 2025

Primær færdiggørelse (Anslået)

17. september 2026

Studieafslutning (Anslået)

17. september 2026

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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