plasma NfL and brain MRI (vMRI, DTI, and ASL [if feasible]) only for the EU cohort
plasma NfL and brain MRI (vMRI, DTI, and ASL [if feasible]) only for the EU cohort: Biomarker assessments are mandated in this protocol (i.e., they are not expected to be done as part of routine clinical practice).
These assessments will be conducted within the same time window as the observational assessments (at approx. 6-month intervals) and are mandated by protocol if not conducted as per clinical practice.
Study summary
Talisman is global clinical study (20058N) in Multiple System Atrophy (MSA) patients. It will be conducted in two regions (China and the European Union \[EU\]). There will be common study objectives between China and EU regions (including prospective assessments for MSA disease progression during routine clinical visits for MSA), and this will allow for data (on common objectives) to be presented overall and stratified by region. There will also be study objectives specific to each region: 1) the clinical assessment for MSA (Unified MSA Rating Scale \[UMSARS\]) has not been validated using standardised methods in China, and so the psychometric properties of the Chinese version of the UMSARS will be examined in Chinese patients in this study; 2) there will be retrospective assessments and prospective protocol-mandated assessments (of Magnetic Resonance Imaging \[MRI\] and bloods biomarkers) and study visits for EU patients.
Because some study objectives are the same for China and the EU (i.e., prospective assessments during routine clinical visits for MSA), and other objectives are specific to each region, there will be one regional protocol for China and one regional protocol for the EU; each describing the study assessments relevant to each region.
Eligibility
Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. The patient must be aged between ≥40 and ≤75 years, at baseline.
2. The patient must be diagnosed with possible or probable MSA of the parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C), according to the Gilman criteria (version 2).
3. The patient must have an anticipated survival of at least 3 years in the opinion of the study investigator, at baseline.
4. The patient had onset of motor MSA symptoms within 5 years prior to the baseline visit in the judgement of the study investigator.
5. The patient must have an UMSARS Part I score of ≤16 (omitting question 11 on sexual function), at baseline.
6. The patient must have normal cognition (i.e., Montreal Cognitive Assessment \[MoCA\] score ≥22), at baseline.
7. The patient's caregiver must have approximately 3 hours per week contact with the patient and be available and able to accompany the patient to routine clinical visits throughout the study, to provide information on the patient's functional abilities.
8. The patient/patient's legally acceptable representative, and the patient's caregiver are willing to provide written voluntary informed consent.
9. The patient's treatments are prescribed according to routine clinical practice and local guidelines/regulations.
Exclusion criteria:
1. The patient has evidence (clinical or on MRI) and/or history of any serious neurological disorder, other intracranial or systemic diseases or conditions resulting in a diagnosis other than MSA.
2. The patient has two or more blood relatives with a history of MSA.
3. The patient is, in the investigator's opinion, unlikely to comply with the protocol.
4. The patient has previously been enroled in this study.
5. The patient is a member of the study personnel or of their immediate family or is a subordinate (or immediate family member of a subordinate) to any of the study personnel.
Primary outcome measure(s)
To describe early MSA disease progression changes in 6-month intervals over 12-months (i.e., baseline, 6-months, 12-months) — baseline, 6 months, 12 months Disease progression will be assessed using the Unified MSA Rating Scale (UMSARS) Part I and II (scores ranging from 0-104); higher scores indicate greater impairment
Changes from baseline to approx. 6-months after baseline and approx.12- months after baseline in plasma NfL concentrations. — baseline, 6 months, 12 months
Percentage change in brain volume in brain regions-of-interest (ROIs), as measured by volumetric MRI (vMRI). — baseline, 6 months, 12 months
Percentage change in tissue integrity in ROIs, as measured by diffusion-tensor imaging (DTI) MRI. — baseline, 6 months, 12 months
Trial sites (8)
Facility
City
Region
Status
Beijing Tiantan Hospital, Capital Medical University
Beijing
China
Beijing Xuanwu Hospital, Capital Medical University
Beijing
China
Beijing Hospital
Beijing
China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing
China
Xiangya Hospital of Central South University
Changsha
China
West China Hospital of Sichuan University
Chengdu
China
Huashan Hospital of Fudan University
Shanghai
China
The Second Affiliated Hospital of Soochow University
Suzhou
China
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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