An Observational Study of Patients With Moderate Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No treatment given.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 50 years — 68 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Japan, Sweden, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other No treatment given
Participants will not receive any investigational treatment in this study.
Primary outcome measures
- 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)]
Secondary outcome measures (2)
- 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)]
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Joe C.Wen & Fam CTR for Adv Care — Irvine
- NYU Langone Health — New York
- NY Presbyt Hosp-W Cornell Med — New York
Sweden · 2 centers
- Neurologimottagningen Lund — Lund
- Region Skane Skanes Universitetssjukhus — Lund
United Kingdom · 2 centers
- Clinical Neuroscience — Cambridge
- University of Cambridge - Clinical Neuroscience — Cambridge
Japan · 1 center
- Keio University Hospital — Shinjuku-ku, Tokyo
Identifiers
NCT: NCT05779475 · NN9001-4704 · U1111-1254-1741