NCT01720810

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

15.7 years

First QC Date

October 31, 2012

Last Update Submit

May 11, 2024

Conditions

Parkinson DiseaseCognitive Impairment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects undergo the following procedures: * Interview to collect data on medical history and demographics * Neurological examination * Questionnaires about mood, activities of daily living, and environmental exposures. * Psychometric tests Study companions might also be asked to complete questionnaires about the participant's thinking and memory, activities of daily living, sleep, and neuropsychiatric symptoms.

You may qualify if:

  • Diagnosis of Parkinson disease
  • Over 18 years of age

You may not qualify if:

  • \- Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

Related Publications (27)

  • 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.

    PMID: 27234211BACKGROUND

  • 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 Parkinson's disease. Clin Park Relat Disord. 2023 May 17;9:100201. doi: 10.1016/j.prdoa.2023.100201. eCollection 2023.

    PMID: 37252677RESULT

  • 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 Parkinson's disease. NPJ Parkinsons Dis. 2022 Jun 20;8(1):78. doi: 10.1038/s41531-022-00344-5.

    PMID: 35725575RESULT

  • 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 Metabolomic and Lipidomic Profiles from Cerebrospinal Fluid. Metabolites. 2022 Mar 22;12(4):277. doi: 10.3390/metabo12040277.

    PMID: 35448464RESULT

  • 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 Sci. 2022 Apr 1;77(4):744-754. doi: 10.1093/gerona/glab212.

    PMID: 34382643RESULT

  • 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 Parkinson's disease. J Clin Exp Neuropsychol. 2021 Jul;43(5):469-480. doi: 10.1080/13803395.2021.1927995. Epub 2021 Aug 6.

    PMID: 34355669RESULT

  • 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-Synuclein-Containing Extracellular Vesicles. Neurology. 2021 May 4;96(18):e2332-e2345. doi: 10.1212/WNL.0000000000011853. Epub 2021 Mar 23.

    PMID: 34032594RESULT

  • 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.

    PMID: 33584497RESULT

  • 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 With and Without Parkinson's Disease. J Gerontol A Biol Sci Med Sci. 2021 Mar 31;76(4):630-637. doi: 10.1093/gerona/glaa300.

    PMID: 33252618RESULT

  • 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. Front Neurol. 2020 Sep 4;11:893. doi: 10.3389/fneur.2020.00893. eCollection 2020.

    PMID: 33013627RESULT

  • 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. doi: 10.1111/jon.12778. Epub 2020 Sep 16.

    PMID: 32937003RESULT

  • 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: 10.1038/s41531-020-00121-2. eCollection 2020.

    PMID: 32885039RESULT

  • 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):1643-1648. doi: 10.3233/JPD-202116.

    PMID: 32741842RESULT

  • 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.2020.05.014. Epub 2020 May 11.

    PMID: 32559629RESULT

  • 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 disease subgroups with increased CSF tau. Brain. 2020 Mar 1;143(3):932-943. doi: 10.1093/brain/awaa021.

    PMID: 32065223RESULT

  • 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 Dec 14;7(1):61-69. doi: 10.1002/mdc3.12870. eCollection 2020 Jan.

    PMID: 31970213RESULT

  • 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 Parkinson's disease. Parkinsonism Relat Disord. 2019 Dec;69:104-110. doi: 10.1016/j.parkreldis.2019.06.014. Epub 2019 Jul 4.

    PMID: 31731260RESULT

  • 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 Clin Exp Neuropsychol. 2019 Oct;41(8):803-813. doi: 10.1080/13803395.2019.1623180. Epub 2019 Jun 10.

    PMID: 31177941RESULT

  • 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: 10.1002/mds.27575. Epub 2018 Dec 10.

    PMID: 30776152RESULT

  • 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. doi: 10.1016/j.prdoa.2019.08.006. Epub 2019 Oct 20.

    PMID: 32368733RESULT

  • 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 dementia in Parkinson's disease. Parkinsonism Relat Disord. 2018 May;50:29-36. doi: 10.1016/j.parkreldis.2018.02.007. Epub 2018 Feb 9.

    PMID: 29478836RESULT

  • 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.parkreldis.2017.08.005. Epub 2017 Aug 9.

    PMID: 28807493RESULT

  • 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, Zabetian CP. Large-scale exploratory genetic analysis of cognitive impairment in Parkinson's disease. Neurobiol Aging. 2017 Aug;56:211.e1-211.e7. doi: 10.1016/j.neurobiolaging.2017.04.009. Epub 2017 Apr 20.

    PMID: 28526295RESULT

  • 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 progression. Proteomics Clin Appl. 2017 Jul;11(7-8):10.1002/prca.201700045. doi: 10.1002/prca.201700045. Epub 2017 Apr 19.

    PMID: 28319654RESULT

  • 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 Clin Transl Neurol. 2016 Nov 25;4(1):15-25. doi: 10.1002/acn3.371. eCollection 2017 Jan.

    PMID: 28078311RESULT

  • 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, Trojanowski JQ. Neuropathological and genetic correlates of survival and dementia onset in synucleinopathies: a retrospective analysis. Lancet Neurol. 2017 Jan;16(1):55-65. doi: 10.1016/S1474-4422(16)30291-5.

    PMID: 27979356RESULT

  • 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, Mattis PJ, Niethammer M, Yearout D, Hu SC, Cholerton BA, Smith M, Mata IF, Montine TJ, Edwards KL, Zabetian CP. Association of GBA Mutations and the E326K Polymorphism With Motor and Cognitive Progression in Parkinson Disease. JAMA Neurol. 2016 Oct 1;73(10):1217-1224. doi: 10.1001/jamaneurol.2016.2245.

    PMID: 27571329RESULT

Biospecimen

Retention: SAMPLES WITH DNA

DNA, plasma, serum, CSF, brain tissue

MeSH Terms

Conditions

Parkinson DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Catherine J Wandell

CONTACT

(206) 277-5516catiejw@uw.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 2, 2012

Study Start

March 1, 2010

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations

US(1)