An Observational Study of Patients With Moderate Parkinson's Disease

NCT05779475 | Enrolling By Invitation

• 2 other identifiers: NN9001-4704U1111-1254-1741
• Study Type: observational
• Target: 96
• Locations: 4 countries
• Sites: 8

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (motor score) in OFF state

  Measured as score. MDS-UPDRS consists of 4 parts - has 65 items/questions in total. Part III assesses the motor function of the patient at the time of the visit conducted in both the OFF and ON state. Each item will receive a score ranging from 0 to 4, where 0 represents the absence of impairment and 4 represents the highest degree of impairment.

  From baseline (week 0) to end of study (13 to 104 weeks from baseline)

Secondary Outcomes (2)

• Change in MDS-UPDRS Part III (motor score) in OFF state

  From last medication adjustment (between week 0 and week 104) to end of study (13 to 104 weeks from baseline)

• Is the patient interested in being considered for participation in a cell therapy transplantation study (yes/no)

  At end of study (13 to 104 weeks from baseline)

Study Arms (1)

Participants with Parkinson's disease

Participants will not receive any investigational treatment in this study. The participants will be treated with anti-Parkinson's disease medication according to local standard of care.

Other: No treatment given

Interventions

No treatment given OTHER

Participants will not receive any investigational treatment in this study.

Participants with Parkinson's disease

Eligibility Criteria

• Age: 50 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Parkinson's disease will be included. The participants will not receive any investigational treatment in this study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (8)

Joe C.Wen & Fam CTR for Adv Care

Irvine, California, 92612, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

NY Presbyt Hosp-W Cornell Med

New York, New York, 10021, United States

Location

Keio University Hospital

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Neurologimottagningen Lund

Lund, 222 42, Sweden

Location

Region Skane Skanes Universitetssjukhus

Lund, 222 42, Sweden

Location

Clinical Neuroscience

Cambridge, CB2 0PY, United Kingdom

Location

University of Cambridge - Clinical Neuroscience

Cambridge, CB2 0PY, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: April 5, 2023
• Primary Completion (Estimated): March 11, 2030
• Study Completion (Estimated): March 11, 2030
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

SE (2); JP (1); GB (2); US (3)