In short
This article discusses a clinical trial involving Latozinemab, a drug being studied for the treatment of neurodegenerative diseases. The trial is designed as a continuation study to provide ongoing access to the drug for participants who have previously been involved in Latozinemab studies. The focus is on assessing the safety and tolerability of the drug in patients with neurodegenerative conditions.
At a glance
- Drug Name
- Latozinemab (AL001)
- Condition Studied
- Neurodegenerative Diseases
- Study Type
- Open-label continuation study
- Dosage
- 60 mg/kg every 4 weeks
- Administration Method
- Intravenous infusion over 60 minutes
- Study Duration
- Up to 190 weeks
- Primary Outcomes
- Number of participants receiving Latozinemab, Duration of treatment
- Secondary Outcomes
- Incidence and severity of adverse events, Development of anti-drug antibodies
What is Latozinemab?
Latozinemab, also known by its alternative name AL001, is an investigational drug currently being studied for its potential in treating neurodegenerative diseases. Neurodegenerative diseases are conditions that affect the brain and nervous system, causing a progressive loss of nerve cells and brain function over time. Examples include Alzheimer's disease, Parkinson's disease, and Huntington's disease.
Target Conditions
The primary focus of the clinical trial for Latozinemab is on neurodegenerative diseases. While specific conditions are not mentioned in the available information, the drug is being studied for its potential to help patients with various types of neurodegenerative disorders.
Clinical Trial Details
The clinical trial for Latozinemab is described as a continuation study. This means that it is designed to provide ongoing access to the drug for patients who have previously participated in earlier Latozinemab studies. The key features of this trial include:
- Open-label design: This means that both the researchers and participants know which treatment is being given. There is no placebo group in this study.
- Duration: The study may last up to 190 weeks (approximately 3.5 years).
- Purpose: The main goals are to provide continued access to Latozinemab and to assess its safety and tolerability in long-term use.
Dosage and Administration
In this clinical trial, Latozinemab is administered as follows:
- Dose: 60 mg/kg of body weight.
- Frequency: Every 4 weeks (q4w).
- Method: Intravenous (IV) infusion, which means the drug is given directly into a vein.
- Duration of infusion: 60 minutes.
Study Objectives
The clinical trial aims to evaluate several aspects of Latozinemab treatment:
- Number of participants receiving the drug: This helps researchers understand how many patients continue long-term treatment.
- Duration of treatment: This information will show how long patients are able to continue taking Latozinemab.
- Safety and tolerability: The study will closely monitor any side effects or adverse reactions to the drug.
Safety Monitoring
The safety of participants is a crucial aspect of this clinical trial. The following measures are in place to monitor safety:
- Adverse Events (AEs) and Serious Adverse Events (SAEs): These are any undesirable experiences associated with the use of the drug. The study will track the number and percentage of participants experiencing AEs or SAEs.
- Severity assessment: The World Health Organization (WHO) toxicity grading scale will be used to evaluate the nature and severity of any AEs and SAEs.
- Anti-Drug Antibodies (ADAs): The study will monitor the development of antibodies against Latozinemab, which could potentially affect its effectiveness or safety.
This comprehensive safety monitoring will help researchers better understand the long-term effects and tolerability of Latozinemab in patients with neurodegenerative diseases.