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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01720810
Other study ID # STUDY00005005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 2010
Est. completion date October 31, 2025

Study information

Verified date May 2024
Source University of Washington
Contact Catherine J Wandell
Phone (206) 277-5516
Email catiejw@uw.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates cognitive impairment in subjects with Parkinson disease (PD) and similar neurological disorder through obtaining longitudinal clinical and neuropsychological data. The long term goal is to have a well-characterized subject population to contribute to our understanding of the natural history, diagnosis and ultimate treatment of cognitive impairment in patients with PD and similar disorders.


Description:

The Pacific Northwest Udall Center (PANUC) Clinical Core has recruited and characterized a cohort of more than 600 individuals with Parkinson's disease (PD) during the initial funding period. Data from the PANUC Clinical Core, in collaboration with other Udall Centers and other academic medical centers, have helped confirm apolipoprotein E (APOE) (1) and glucocerebrosidase (glucosidase, beta, acid or GBA) (2)as genes that increase the risk and modify the phenotype (1) of cognitive decline in PD. Understanding the mechanisms underlying these gene effects is the focus of this renewal application, and the Clinical Core will provide well-characterized PD and control subjects of appropriate genotypes for PANUC projects. In addition, the majority of the existing cohort will be retained for additional longitudinal clinical and neuropsychological testing follow-up to support ongoing genetic and biomarker studies, with a refined battery of tests and a uniform biannual frequency of visits designed to maximize efficiency. Balance and gait testing (already piloted at the Portland site) will be added to the test battery for the entire cohort as an innovation that is thought to reflect higher order CNS function closely related to cognition. This innovation leverages the expertise of Dr. Horak, an investigator introduced to the PANUC by way of PANUC Pilot Award funding during the last funding period. As in the current cycle, Clinical Core subjects will be followed in identical fashion at two sites: one at UW directed by Dr. Hu, and the other at OHSU directed by Core Leader Dr. Quinn. Project 3 leader Dr. Horak will oversee balance and gait testing at OHSU and Dr. Kelly will oversee balance and gait testing at UW.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date October 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of Parkinson disease - Over 18 years of age Exclusion Criteria: - Under 18 years of age

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States VA Puget Sound Health Care System Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (27)

Cholerton B, Johnson CO, Fish B, Quinn JF, Chung KA, Peterson-Hiller AL, Rosenthal LS, Dawson TM, Albert MS, Hu SC, Mata IF, Leverenz JB, Poston KL, Montine TJ, Zabetian CP, Edwards KL. Sex differences in progression to mild cognitive impairment and demen — View Citation

Cholerton B, Poston KL, Tian L, Quinn JF, Chung KA, Hiller AL, Hu SC, Specketer K, Montine TJ, Edwards KL, Zabetian CP. Participant and Study Partner Reported Impact of Cognition on Functional Activities in Parkinson's Disease. Mov Disord Clin Pract. 2019 — View Citation

Cholerton BA, Poston KL, Yang L, Rosenthal LS, Dawson TM, Pantelyat A, Edwards KL, Tian L, Quinn JF, Chung KA, Hiller AL, Hu SC, Montine TJ, Zabetian CP. Semantic fluency and processing speed are reduced in non-cognitively impaired participants with Parki — View Citation

Cooper CA, Jain N, Gallagher MD, Weintraub D, Xie SX, Berlyand Y, Espay AJ, Quinn J, Edwards KL, Montine T, Van Deerlin VM, Trojanowski J, Zabetian CP, Chen-Plotkin AS. Common variant rs356182 near SNCA defines a Parkinson's disease endophenotype. Ann Cli — View Citation

Davis MY, Johnson CO, Leverenz JB, Weintraub D, Trojanowski JQ, Chen-Plotkin A, Van Deerlin VM, Quinn JF, Chung KA, Peterson-Hiller AL, Rosenthal LS, Dawson TM, Albert MS, Goldman JG, Stebbins GT, Bernard B, Wszolek ZK, Ross OA, Dickson DW, Eidelberg D, M — View Citation

Gryc W, Roberts KA, Zabetian CP, Weintraub D, Trojanowski JQ, Quinn JF, Hiller AL, Chung KA, Poston KL, Yang L, Hu SC, Edwards KL, Montine TJ, Cholerton BA. Hallucinations and Development of Dementia in Parkinson's Disease. J Parkinsons Dis. 2020;10(4):16 — View Citation

Hendershott TR, Zhu D, Llanes S, Zabetian CP, Quinn J, Edwards KL, Leverenz JB, Montine T, Cholerton B, Poston KL. Comparative sensitivity of the MoCA and Mattis Dementia Rating Scale-2 in Parkinson's disease. Mov Disord. 2019 Feb;34(2):285-291. doi: 10.1 — View Citation

Hong Z, Tian C, Stewart T, Aro P, Soltys D, Bercow M, Sheng L, Borden K, Khrisat T, Pan C, Zabetian CP, Peskind ER, Quinn JF, Montine TJ, Aasly J, Shi M, Zhang J. Development of a Sensitive Diagnostic Assay for Parkinson Disease Quantifying alpha-Synuclei — View Citation

Hwangbo N, Zhang X, Raftery D, Gu H, Hu SC, Montine TJ, Quinn JF, Chung KA, Hiller AL, Wang D, Fei Q, Bettcher L, Zabetian CP, Peskind E, Li G, Promislow DEL, Franks A. A Metabolomic Aging Clock Using Human Cerebrospinal Fluid. J Gerontol A Biol Sci Med S — View Citation

Hwangbo N, Zhang X, Raftery D, Gu H, Hu SC, Montine TJ, Quinn JF, Chung KA, Hiller AL, Wang D, Fei Q, Bettcher L, Zabetian CP, Peskind ER, Li G, Promislow DEL, Davis MY, Franks A. Predictive Modeling of Alzheimer's and Parkinson's Disease Using Metabolomi — View Citation

Irwin DJ, Grossman M, Weintraub D, Hurtig HI, Duda JE, Xie SX, Lee EB, Van Deerlin VM, Lopez OL, Kofler JK, Nelson PT, Jicha GA, Woltjer R, Quinn JF, Kaye J, Leverenz JB, Tsuang D, Longfellow K, Yearout D, Kukull W, Keene CD, Montine TJ, Zabetian CP, Troj — View Citation

Kim HM, Nazor C, Zabetian CP, Quinn JF, Chung KA, Hiller AL, Hu SC, Leverenz JB, Montine TJ, Edwards KL, Cholerton B. Prediction of cognitive progression in Parkinson's disease using three cognitive screening measures. Clin Park Relat Disord. 2019;1:91-97 — View Citation

Licking N, Murchison C, Cholerton B, Zabetian CP, Hu SC, Montine TJ, Peterson-Hiller AL, Chung KA, Edwards K, Leverenz JB, Quinn JF. Homocysteine and cognitive function in Parkinson's disease. Parkinsonism Relat Disord. 2017 Nov;44:1-5. doi: 10.1016/j.par — View Citation

Martini DN, Morris R, Kelly VE, Hiller A, Chung KA, Hu SC, Zabetian CP, Oakley J, Poston K, Mata IF, Edwards KL, Lapidus JA, Grabowski TJ, Montine TJ, Quinn JF, Horak F. Sensorimotor Inhibition and Mobility in Genetic Subgroups of Parkinson's Disease. Fro — View Citation

Martini DN, Morris R, Madhyastha TM, Grabowski TJ, Oakley J, Hu SC, Zabetian CP, Edwards KL, Hiller A, Chung K, Ramsey K, Lapidus JA, Cholerton B, Montine TJ, Quinn JF, Horak FB. Relationships Between Sensorimotor Inhibition and Mobility in Older Adults W — View Citation

Mata IF, Johnson CO, Leverenz JB, Weintraub D, Trojanowski JQ, Van Deerlin VM, Ritz B, Rausch R, Factor SA, Wood-Siverio C, Quinn JF, Chung KA, Peterson-Hiller AL, Espay AJ, Revilla FJ, Devoto J, Yearout D, Hu SC, Cholerton BA, Montine TJ, Edwards KL, Zab — View Citation

Morris R, Martini DN, Kelly VE, Smulders K, Ramsey K, Hiller A, Chung KA, Hu SC, Zabetian CP, Poston KL, Mata IF, Edwards KL, Lapidus J, Cholerton B, Montine TJ, Quinn JF, Horak F. Gait and balance in apolipoprotein E4 allele carriers in older adults and — View Citation

Morris R, Martini DN, Ramsey K, Kelly VE, Smulders K, Hiller A, Chung KA, Hu SC, Zabetian CP, Poston KL, Mata IF, Edwards KL, Lapidus J, Cholerton B, Montine TJ, Quinn JF, Horak F. Cognition as a mediator for gait and balance impairments in GBA-related Pa — View Citation

Morris R, Martini DN, Smulders K, Kelly VE, Zabetian CP, Poston K, Hiller A, Chung KA, Yang L, Hu SC, Edwards KL, Cholerton B, Grabowski TJ, Montine TJ, Quinn JF, Horak F. Cognitive associations with comprehensive gait and static balance measures in Parki — View Citation

Palmer WC, Cholerton BA, Zabetian CP, Montine TJ, Grabowski TJ, Rane S. Resting-State Cerebello-Cortical Dysfunction in Parkinson's Disease. Front Neurol. 2021 Jan 28;11:594213. doi: 10.3389/fneur.2020.594213. eCollection 2020. — View Citation

Phongpreecha T, Cholerton B, Mata IF, Zabetian CP, Poston KL, Aghaeepour N, Tian L, Quinn JF, Chung KA, Hiller AL, Hu SC, Edwards KL, Montine TJ. Multivariate prediction of dementia in Parkinson's disease. NPJ Parkinsons Dis. 2020 Aug 25;6:20. doi: 10.103 — View Citation

Rane S, Koh N, Oakley J, Caso C, Zabetian CP, Cholerton B, Montine TJ, Grabowski T. Arterial spin labeling detects perfusion patterns related to motor symptoms in Parkinson's disease. Parkinsonism Relat Disord. 2020 Jul;76:21-28. doi: 10.1016/j.parkreldis — View Citation

Rane S, Owen J, Hippe DS, Cholerton B, Zabetian CP, Montine T, Grabowski TJ. White Matter Lesions in Mild Cognitive Impairment and Idiopathic Parkinson's Disease: Multimodal Advanced MRI and Cognitive Associations. J Neuroimaging. 2020 Nov;30(6):843-850. — View Citation

Shi M, Kovac A, Korff A, Cook TJ, Ginghina C, Bullock KM, Yang L, Stewart T, Zheng D, Aro P, Atik A, Kerr KF, Zabetian CP, Peskind ER, Hu SC, Quinn JF, Galasko DR, Montine TJ, Banks WA, Zhang J. CNS tau efflux via exosomes is likely increased in Parkinson's disease but not in Alzheimer's disease. Alzheimers Dement. 2016 Nov;12(11):1125-1131. doi: 10.1016/j.jalz.2016.04.003. Epub 2016 May 24. — View Citation

Specketer K, Zabetian CP, Edwards KL, Tian L, Quinn JF, Peterson-Hiller AL, Chung KA, Hu SC, Montine TJ, Cholerton BA. Visuospatial functioning is associated with sleep disturbance and hallucinations in nondemented patients with Parkinson's disease. J Cli — View Citation

Wilson EN, Swarovski MS, Linortner P, Shahid M, Zuckerman AJ, Wang Q, Channappa D, Minhas PS, Mhatre SD, Plowey ED, Quinn JF, Zabetian CP, Tian L, Longo FM, Cholerton B, Montine TJ, Poston KL, Andreasson KI. Soluble TREM2 is elevated in Parkinson's diseas — View Citation

Yang L, Stewart T, Shi M, Pottiez G, Dator R, Wu R, Aro P, Schuster RJ, Ginghina C, Pan C, Gao Y, Qian W, Zabetian CP, Hu SC, Quinn JF, Zhang J. An alpha-synuclein MRM assay with diagnostic potential for Parkinson's disease and monitoring disease progress — View Citation

* Note: There are 27 references in allClick here to view all references

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