An Observational Study of Patients With Moderate Parkinson's Disease

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.

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Key information

Conditions

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

Age range

50 year–68 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Keio University Hospital, Shinjuku-ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No treatment given

Other

Participants will not receive any investigational treatment in this study.

Primary outcomes

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

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

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.

Secondary outcomes

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

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

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

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

Measured as count of participants

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: TRANSCEND 1

Important dates

Study start: 2023
Primary completion: 2030
Study completion: 2030
First posted: Mar 22, 2023
Registry last updated: Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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