Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation (LRRK2)
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Descripción detallada
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
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Nathan Alexander, BSc
- Número de teléfono: 734-998-6894
- Correo electrónico: natealex@med.umich.edu
Ubicaciones de estudio
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- Reclutamiento
- University of Michigan
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Investigador principal:
- Prabesh Kanel, PhD
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Contacto:
- Nathan Alexander, BSc
- Número de teléfono: 734-998-6894
- Correo electrónico: natealex@med.umich.edu
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Contacto:
- Gerianne Que, BSc
- Número de teléfono: 734-998-4790
- Correo electrónico: queg@med.umich.edu
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- History of deep brain stimulation surgery.
- Pregnant or nursing.
- Suicidal ideation, as indicated by a response of 2 or 3 on question 9 of the Beck Depression Inventory.
- Cognitive impairment that results in the inability to give consent, as demonstrated by the Decision Making Capacity Tool.
- Any other condition or criterion that would preclude safe and meaningful participation in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
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LRRK2
Individuals with PD and LRRK2 genetic mutation.
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iPD
Individuals with PD and without LRRK2 genetic mutation (Pre-existing cohorts, not recruiting).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cholinergic Differences Between leucine-rich repeat kinase 2 (LRRK2) Parkinson's disease (PD) and Idiopathic/non-LRRK2 PD (iPD)
Periodo de tiempo: Baseline
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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.
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Baseline
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Dopaminergic Differences Between LRRK2-PD and iPD
Periodo de tiempo: Baseline
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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.
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Baseline
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Association of Cholinergic Data With Cognition in LRRK2-PD
Periodo de tiempo: Baseline
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Association of the global average cholinergic uptake (represented by VAChT uptake) with the global average cognitive z-score of individuals with LRRK2-PD.
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Baseline
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Association of Cholinergic Data With Postural Instability and Gait Difficulties (PIGD) in LRRK2-PD
Periodo de tiempo: Baseline
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Association of the global average cholinergic uptake (represented by VAChT uptake) with the global average PIGD score of individuals with LRRK2-PD.
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Baseline
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Association of Dopaminergic Data With Cognition in LRRK2-PD
Periodo de tiempo: Baseline
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Association of the global average dopaminergic uptake (represented by DAT uptake) with the global average cognitive z-score of individuals with LRRK2-PD.
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Baseline
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Association of Dopaminergic Data With PIGD in LRRK2-PD
Periodo de tiempo: Baseline
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Association of the global average dopaminergic uptake (represented by DAT uptake) with the global average PIGD score of individuals with LRRK2-PD.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Prabesh Kanel, PhD, University of Michigan
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- HUM00276006
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
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