An Observational Study of Patients With Moderate Parkinson's Disease

Parkinson Disease Clinical Trial

— TRANSCEND 1  

Official title:

An Observational Study of Patients With Moderate Parkinson's Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05779475
• Other study ID #: NN9001-4704
• Secondary ID: U1111-1254-1741
• Status: Enrolling by invitation
• Start date: April 5, 2023
• Est. completion date: October 22, 2025

Study information

• Verified date: January 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 96
• Est. completion date: October 22, 2025
• Est. primary completion date: October 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• No treatment given
Participants will not receive any investigational treatment in this study.

Locations

Country	Name	City	State
Japan	Keio University Hospital	Shinjuku-ku, Tokyo
Sweden	Neurologimottagningen Lund	Lund
United Kingdom	Clinical Neuroscience	Cambridge
United States	NY Presbyt Hosp-W Cornell Med	New York	New York
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Japan,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in 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 last medication adjustment (between week 0 and week 104) to end of study (13 to 104 weeks from baseline)
Secondary	Is the patient interested in being considered for participation in a cell therapy transplantation study (yes/no)	Measured as count of participants	At end of study (13 to 104 weeks from baseline)