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Tests treatment safety and results for Multiple System Atrophy - Parkinsonian Subtype (MSA-P)
Official title The Study of Safety and Preliminary Efficacy of Aleeto in Patients With MultIple System Atrophy
ClinicalTrials.gov ID: NCT06765733
What this study is testing
What is Aleeto?
Aleeto is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for multiple system atrophy - parkinsonian subtype (msa-p).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study. At the end of the PROBE study, patients who have completed the study may opt to enter the open-label extension (OLE) study.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75
You may be able to join if
- 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...
You likely can't join if
- Head MRI at screening showing evidence of other CNS lesions consistent with a diagnosis of neurodegenerative disease other than MSA;
- Patients with MMSE scores indicative of dementia prior to enrolment (≤17 points for illiterate individuals, ≤20 points for individuals with...
- Head MRI at screening showing other significant pathological findings including but not limited to: cerebral hemorrhage, acute phase of cerebral...
- Presence of immune disorders that are inadequately controlled or require treatment with biological agents;
- Known history of allergy to biological agents such as proteins and cell products;
- Patients who have received any vaccination within 1 month;
See the full eligibility 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...
- Head MRI at screening showing evidence of other CNS lesions consistent with a diagnosis of neurodegenerative disease other than MSA;
- 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...
- 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...
- Presence of immune disorders that are inadequately controlled or require treatment with biological agents;
- Known history of allergy to biological agents such as proteins and cell products;
- Patients who have received any vaccination within 1 month;
- Patients with pre-existing, clearly diagnosed malignant tumor or being treated with anti-tumor drugs;
- Patients with a history of clearly diagnosed epilepsy or taking antiepileptic drugs;
- Presence of lumbar spine disease and deformity or other contraindications to lumbar puncture;
- Patients with abnormal coagulation function prior to enrolment (e.g., platelet count \ 3 s), previous diagnosis of coagulation disorders such as hemophilia, and patients currently receiving more than two types of...
- Contraindications to MRI (e.g. claustrophobia, internal placement of pacemakers or paramagnetic metals, etc.);
- 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...
- Hepatitis B active infection (hepatitis B surface antigen positive and/or serum HBV DNA positive or serum HBV DNA \> 2 × 10E8 IU/ml;
- Hepatitis C virus antibody positive or history of positive test;
- Positive HIV test or history of positive test;
- Patients with a combined history of alcohol or drug abuse or alcohol or drug dependence within 2 years;
- Other psychiatric disorders diagnosed according to DSM-V diagnostic criteria, or significant suicide intent;
- Patients who are pregnant, breast-feeding, or who are likely to become pregnant and plan to become pregnant;
- Patients who are participating in other treatment 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...
- Unable to be cooperative and complete the follow-up due to other reasons.
- Patients who, in the opinion of the investigator, are not suitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.