Parkinson DiseasePANUCNCT01720810
Pacific Northwest Udall Center (PANUC) Clinical Core
An observational study of Parkinson Disease and Cognitive Impairment, run by University of Washington at 1 site in United States.
Trial summary
This study evaluates cognitive impairment in subjects with Parkinson disease (PD) and similar neurological disorder through obtaining longitudinal clinical and neuropsychological data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Cognitive Impairment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of Parkinson disease
- Over 18 years of age
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Puget Sound Health Care System
Seattle, Washington, 98108
Catherine J Wandell, 206-277-5516, catiejw@uw.edu
Cyrus P Zabetian, MD, MS
About this study
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.
Read the detailed 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.
- Conditions
- Parkinson Disease, Cognitive Impairment
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startMar 2010
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cyrus Zabetian, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720810
- Sponsor's protocol ID
- STUDY00005005
- Acronym
- PANUC
- Status last verified
- May 2024
- First submitted
- 31 Oct 2012
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27234211Morris 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.
PubMed 37252677Morris 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.
PubMed 35725575Hwangbo 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.
PubMed 35448464Hwangbo 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.
PubMed 34382643Cholerton 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.
PubMed 34355669Hong 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.
PubMed 34032594Palmer 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.
PubMed 33584497Martini 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.
PubMed 33252618Martini 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.
PubMed 33013627Rane 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.
PubMed 32937003Phongpreecha 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.
PubMed 32885039Gryc 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.
PubMed 32741842Rane 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.
PubMed 32559629Wilson 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.
PubMed 32065223
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacific Northwest Udall Center (PANUC) Clinical Core
- ClinicalTrials.gov ID
- NCT01720810
- Acronym / sponsor ID
- PANUC / STUDY00005005
- Conditions
- Parkinson Disease, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Mar 2010 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of Parkinson disease
- Over 18 years of age
Key exclusion criteria (1 listed)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 27234211Shi 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.
- Results publication: PubMed 37252677Morris 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.
- Results publication: PubMed 35725575Morris 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.
- Results publication: PubMed 35448464Hwangbo 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.
- Results publication: PubMed 34382643Hwangbo 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.
- Results publication: PubMed 34355669Cholerton 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.
- Results publication: PubMed 34032594Hong 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.
- Results publication: PubMed 33584497Palmer 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.
- Results publication: PubMed 33252618Martini 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.
- Results publication: PubMed 33013627Martini 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.
- Results publication: PubMed 32937003Rane 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.
- Results publication: PubMed 32885039Phongpreecha 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.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Cognitive Impairment, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine J Wandell ((206) 277-5516, catiejw@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01720810, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.