Status:
UNKNOWN
Safety and Preliminary Efficacy of Aleeto in Amyotrophic Lateral Sclerosis
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is a single-center, randomized, double-blind, placebo parallel-controlled, dose-escalation clinical study. The aim of this study was to evaluate the safety, tolerability, and preliminary ef...
Detailed Description
Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease, which is characterized by progressive loss of number and function of upper and lower motor neurons located in the brain and sp...
Eligibility Criteria
Inclusion
- Subjects who are qualified for the clinical trial program cycle judged by well-trained physicians;
- 18 years old≤ age≤ 75 years old, males or females;
- Forced vital capacity ≥ 80% of predicted vital capacity during the screening period;
- The total score of the ALSFRS-R scale ≥ 30 points and ≤40 points during enrollment, and the respiratory function item ≥ 3 points;
- Diagnosis of confirmed or probable ALS in accordance with the revised EI Escorial diagnostic criteria for amyotrophic lateral sclerosis of the World Federation of Neurology;
- Subjects or their legal representatives clearly understand and voluntarily participate in the study and sign the informed consent form;
- Subjects (including male subjects) are willing to have no birth plan and voluntarily take effective contraceptive measures during the entire study period and within 3 months after the end of the study, and have no plan to donate sperm or eggs.
Exclusion
- Diagnosed with familial ALS (based on family history);
- With obvious cognitive impairment (MMSE scale: ≤19 points in the illiteracy group，≤ 22 points in the primary school group, and ≤26 points in the junior high school group (more than 8 years of education);
- Obvious dysphagia;
- Positive HIV test or history of positive test;
- Positive hepatitis C virus antibody or positive test history;
- Hepatitis B active infection (hepatitis B surface antigen positive and/or serum HBV DNA positive or serum HBV DNA \> 2 × 108 IU/ml;
- Have used other investigational drugs within 1 month or within 5 drug half-lives;
- Diseases and deformities of the lumbar spine;
- Have other conditions known to be associated with motor neuron dysfunction that may confuse or obscure an ALS diagnosis;
- Other psychiatric disorders diagnosed according to DSM-V diagnostic criteria, or significant suicide intent;
- 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);
- Permanently dependent on ventilator-assisted ventilation;
- History of alcohol and drug abuse; Edaravone users;
- Patients who are pregnant, breast-feeding, or who are likely to become pregnant and plan to become pregnant;
- Patients participating in other clinical trials or using other biological agents, drugs, or devices under investigation;
- Patients who have received any vaccinations within 28 days;
- Contraindications to MRI (eg, claustrophobia);
- Unable to be cooperative and complete the follow-up due to other reasons.
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06181526
Start Date
December 15 2023
End Date
October 30 2024
Last Update
December 26 2023
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, China, 100050