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An Observational Study of Patients With Moderate Parkinson's Disease | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATION

An Observational Study of Patients With Moderate Parkinson's Disease

NCT05779475•Novo Nordisk A/S

Summary

The main purpose of this study is to follow and observe a group of people living with Parkinson's disease to see how study participation affects their signs and symptoms in the months after starting in the study. While taking part in this study participants will take their usual medication as prescribed. However, the study doctor may recommend adjustments to their medication to provide a better treatment of their Parkinson's disease. Participation will last from 3 up to 24 months. During visits to the clinic, the study doctor or study nurse will evaluate signs and symptoms of Parkinson's disease using several different assessments. At a minimum of 2 visits participants will be asked to undergo 'off'-assessments.

Eligibility

Age

50 - 68 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, aged 50-68 years (both inclusive) at the time of signing informed consent.
•Diagnosed with Parkinson's disease using the Movement Disorder Society (MDS) criteria (fulfilling the definition of clinically probable Parkinson's disease).
•Moderate Parkinson's disease, e.g. as defined by i) modified Hoehn and Yahr stage 2-3 in OFF state and ii) MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score greater than or equal to (≥) 30 in OFF state, both as judged by the investigator.
•Patient has symptoms that are not adequately controlled by existing oral anti-Parkinson's disease medications, i.e., having both ON and OFF periods, as judged by the investigator.
•Parkinson's disease duration greater than (\>) 5 years and lesser than or equal to (≤) 12 years from diagnosis at the time of signing informed consent.
•Potential candidate for a future cell therapy transplantation, as judged by the investigator.
•Life expectancy \>7 years as judged by the investigator.

Exclusion Criteria

•Any atypical or secondary Parkinson's disease, or non-Parkinson's disease-suspected cause(s) of, or contributors to, parkinsonism, as judged by the investigator.
•Significant drug-induced dyskinesias as judged by the investigator, e.g., as defined by a score of \> 2 in the Abnormal Involuntary Movement Scale (AIMS), in any body part in the ON state.
•Tremor-dominant Parkinson's disease, as judged by the investigator.
•Cognitive impairment predictive of dementia (including Parkinson's disease dementia) or other cognitive dysfunction as judged by the investigator, e.g., as defined by Montreal Cognitive Assessment (MoCA) score ≤ 24, or evidence of major neurocognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) criteria.
•Major medical or psychiatric disorder (e.g., depression (Montgomery-Asberg Depression Rating Scale (MADRS) \>20) or psychosis), or other disease making the patient unsuited for participation in the study, as judged by the investigator.
•Treatment for dystonia or spasticity within 3 months of screening (Botox for a focal dystonia is allowed).
•Substantial neurological symptoms not accounted for by Parkinson's disease, including active seizure disorder, as judged by the investigator.

Locations (8)

Joe C.Wen & Fam CTR for Adv Care

Irvine, California, United States

NYU Langone Health

New York, New York, United States

NY Presbyt Hosp-W Cornell Med

New York, New York, United States

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Neurologimottagningen Lund

Lund, Sweden

Region Skane Skanes Universitetssjukhus

Lund, Sweden

Clinical Neuroscience

Cambridge, United Kingdom

University of Cambridge - Clinical Neuroscience

Cambridge, United Kingdom

Key Dates

Start Date

April 5, 2023

Primary Completion Date

March 11, 2030

Completion Date

March 11, 2030

Last Updated

December 24, 2025

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease

Interventions

No treatment given

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Observational Study of Patients With Moderate Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

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