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Latozinemab

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.

Table of Contents

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[1]. 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[1]. 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[1]. 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[1].
  • Duration: The study may last up to 190 weeks (approximately 3.5 years)[1].
  • Purpose: The main goals are to provide continued access to Latozinemab and to assess its safety and tolerability in long-term use[1].

Dosage and Administration

In this clinical trial, Latozinemab is administered as follows:

  • Dose: 60 mg/kg of body weight[1].
  • Frequency: Every 4 weeks (q4w)[1].
  • Method: Intravenous (IV) infusion, which means the drug is given directly into a vein[1].
  • Duration of infusion: 60 minutes[1].

Study Objectives

The clinical trial aims to evaluate several aspects of Latozinemab treatment:

  1. Number of participants receiving the drug: This helps researchers understand how many patients continue long-term treatment[1].
  2. Duration of treatment: This information will show how long patients are able to continue taking Latozinemab[1].
  3. Safety and tolerability: The study will closely monitor any side effects or adverse reactions to the drug[1].

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[1].
  • Severity assessment: The World Health Organization (WHO) toxicity grading scale will be used to evaluate the nature and severity of any AEs and SAEs[1].
  • Anti-Drug Antibodies (ADAs): The study will monitor the development of antibodies against Latozinemab, which could potentially affect its effectiveness or safety[1].

This comprehensive safety monitoring will help researchers better understand the long-term effects and tolerability of Latozinemab in patients with neurodegenerative diseases.

Aspect Details
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

FAQ

  • What is Latozinemab? Latozinemab, also known as AL001, is a drug being studied for the treatment of neurodegenerative diseases. It is administered through intravenous (IV) infusion.
  • What is the purpose of this continuation study? The purpose of this study is to provide continued access to Latozinemab for participants who have previously been involved in Latozinemab studies, and to further assess its safety and tolerability.
  • How is Latozinemab administered in this study? In this study, all participants receive Latozinemab through an IV infusion over 60 minutes, at a dose of 60 mg/kg every 4 weeks.
  • How long does the study last? The study can last up to 190 weeks, which is approximately 3.5 years.
  • What are the main outcomes being measured in this study? The main outcomes include the number of participants receiving Latozinemab, the duration of treatment, and the incidence and severity of adverse events and serious adverse events. The study also measures the development of anti-drug antibodies.

Ongoing Clinical Trials on Latozinemab

  • Study of Latozinemab for Patients with Neurodegenerative Diseases Who Previously Participated in a Latozinemab Study

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Portugal +1

  • Study on the Effects of Latozinemab for Patients with Frontotemporal Dementia Due to Progranulin Gene Mutations

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Greece Italy The Netherlands +3

Glossary

  • Neurodegenerative Diseases: A group of conditions that affect the brain and nervous system, causing a progressive loss of nerve cells and/or their function. Examples include Alzheimer's disease and Parkinson's disease.
  • Open-label study: A type of clinical trial where both the researchers and participants know which treatment is being administered.
  • Intravenous (IV) infusion: A method of delivering medications directly into a vein using a needle or catheter.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Events (SAEs): An adverse event that results in death, is life-threatening, requires hospitalization, causes a significant incapacity, or is otherwise considered medically significant.
  • Anti-Drug Antibodies (ADAs): Proteins produced by the immune system in response to a drug, which may affect the drug's effectiveness or cause side effects.
  • WHO toxicity grading scale: A standardized system used to classify the severity of side effects in clinical trials, developed by the World Health Organization.

References