Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT05453058
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT05453058
Study Brief:
Protocol Section:
NCT05453058