Aleeto for Parkinsonian multiple system atrophy (MSA-P)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, randomized, open-label study with blinded outcome assessment (PROBE) conducted at Beijing Tiantan Hospital to test safety, tolerability, and preliminary efficacy of Aleeto in patients with MSA-P. Aleeto is a nerve‑repair protein therapy developed by Darwin Origin (Beijing) Biopha that is being given to participants and monitored for adverse events and clinical changes. Eligible participants are adults with clinically probable or confirmed MSA-P, poor response to levodopa, symptom onset within five years, and the ability to walk at least 10 meters. Those who complete the core study may opt into an open-label extension for additional follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1.30 years ≤ 75 years of age, regardless of sex; 2.Clinically confirmed or clinically probable MSA-P; 3.Poor response to levodopa; 4.MSA-related motor symptom onset ≤5 years at first visit; 5.Walking ≥10 meters independently or with a walking aid; 6.Expected survival of ≥1 year, as determined by the investigator; 7.Signed informed consent.

Exclusion Criteria:

1. Head MRI at screening showing evidence of other CNS lesions consistent with a diagnosis of neurodegenerative disease other than MSA;
2. Patients with MMSE scores indicative of dementia prior to enrolment (≤17 points for illiterate individuals, ≤20 points for individuals with elementary school education, ≤24 points for individuals with junior high school education or higher) or those with a prior confirmed diagnosis of dementia;
3. Head MRI at screening showing other significant pathological findings including but not limited to: cerebral hemorrhage, acute phase of cerebral infarction, aneurysm, vascular malformation, infectious lesion, brain tumor or other space-occupying lesion (meningiomas or arachnoid cysts with a maximum diameter of \<1 cm need not be excluded);
4. Presence of immune disorders that are inadequately controlled or require treatment with biological agents;
5. Known history of allergy to biological agents such as proteins and cell products;
6. Patients who have received any vaccination within 1 month;
7. Patients with pre-existing, clearly diagnosed malignant tumor or being treated with anti-tumor drugs;
8. Patients with a history of clearly diagnosed epilepsy or taking antiepileptic drugs;
9. Presence of lumbar spine disease and deformity or other contraindications to lumbar puncture;
10. Patients with abnormal coagulation function prior to enrolment (e.g., platelet count \<100 × 10E9/L; prothrombin time \[PT\] \>3 s), previous diagnosis of coagulation disorders such as hemophilia, and patients currently receiving more than two types of antiplatelet medication;
11. Contraindications to MRI (e.g. claustrophobia, internal placement of pacemakers or paramagnetic metals, etc.);
12. With severe hepatic insufficiency, renal insufficiency or severe cardiac insufficiency (severe hepatic insufficiency refers to ALT value≥2.0 times the upper limit of normal value or AST value≥2.0 times the upper limit of normal value; severe renal insufficiency refers to CRE≥1.5 times the upper limit of normal value or eGFR\<40mL/min/1.73m2; severe cardiac insufficiency refers to NYHA class 3-4);
13. Hepatitis B active infection (hepatitis B surface antigen positive and/or serum HBV DNA positive or serum HBV DNA \> 2 × 10E8 IU/ml;
14. Hepatitis C virus antibody positive or history of positive test;
15. Positive HIV test or history of positive test;
16. Patients with a combined history of alcohol or drug abuse or alcohol or drug dependence within 2 years;
17. Other psychiatric disorders diagnosed according to DSM-V diagnostic criteria, or significant suicide intent;
18. Patients who are pregnant, breast-feeding, or who are likely to become pregnant and plan to become pregnant;
19. Patients who are participating in other interventional studies or using other investigational biological agents, drugs, or devices, and patients who have used other experimental drugs within 1 month or within 5 drug half-lives;
20. Unable to be cooperative and complete the follow-up due to other reasons.
21. Patients who, in the opinion of the investigator, are not suitable for participation in this trial.

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Yilong Wang, M.D. — Beijing Tiantan Hospital, Capital Medical University, Beijing, China
• Study coordinator: Weiqi Chen, M.D.
• Email: weiqichen@aliyun.com
• Phone: 8615652813380

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.