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

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying neurodegenerative diseases, which are conditions that involve the gradual loss of nerve cells in the brain. The treatment being investigated is called latozinemab, a solution given through an intravenous infusion, meaning it is administered directly into the bloodstream. The purpose of this study is to provide continued access to latozinemab for participants who have previously taken part in a study involving this treatment.

Participants in this study will receive latozinemab over a period of time, with the maximum treatment period being 39 weeks. The study will monitor the number of participants receiving the treatment and the duration of their treatment. Additionally, the study will observe any adverse events, which are unwanted effects that may occur during the treatment, and the development of any antibodies against latozinemab, which are proteins the body might produce in response to the treatment.

The study will also assess the participants' condition using specific scales every three months. These scales help to evaluate the severity of the disease and any changes in the participants' condition over time. The study aims to gather information on the safety and effects of latozinemab in individuals with neurodegenerative diseases, ensuring that those who have previously benefited from the treatment can continue to receive it.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    The initial visit marks the beginning of the study. Participants must have completed a previous study involving latozinemab.

    Women must confirm they are not pregnant or lactating. A pregnancy test is required for women of childbearing potential.

    Men must agree to use contraception and not donate sperm during the study and for 10 weeks after the last dose.

  2. Step 2

    Treatment administration

    Latozinemab is administered as a solution through an intravenous infusion. The frequency and dosage are determined by the study protocol.

    Participants will receive the treatment for the duration specified in the study, which aims to continue access to latozinemab.

  3. Step 3

    Monitoring and assessments

    Participants will be monitored for any adverse events or serious adverse events. The nature and severity of these events will be recorded.

    Every three months, assessments will be conducted to evaluate the clinical status using specific scales.

  4. Step 4

    Completion and follow-up

    Upon completion of the treatment phase, participants must agree not to donate blood or blood products for one year after the final dose.

    The study is estimated to end by July 31, 2027, with recruitment starting on August 31, 2024.

Who can join the trial?

6 criteria

  • The participant must have given their agreement to join the study, known as informed consent. If a person cannot give this consent themselves, they cannot join the study.
  • The participant must have finished their previous study with the medicine called latozinemab successfully.
  • At the first visit, women must not be pregnant or breastfeeding. They must either not be able to have children or agree to use a very effective method to prevent pregnancy from the first visit until 10 weeks after the last dose of the study medicine. Women who can have children must take a pregnancy test at the Transition Visit.
  • Men must agree to use a method to prevent pregnancy and not donate sperm from the first visit until 10 weeks after the last dose of the study medicine.
  • The participant agrees not to donate blood or blood products for transfusion during the study and for 1 year after the final dose of the study medicine.
  • The participant must be willing and able to follow the study rules, as judged by the study doctor.

Who cannot join the trial?

2 criteria

  • Participants who have not previously participated in a study involving the drug **latozinemab**.
  • Individuals who do not have a **neurodegenerative disease**. This refers to conditions where the brain and nerves gradually lose function over time.
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Investigated drugs

Latozinemab is a medication being studied for its potential use in treating neurodegenerative diseases. This trial aims to provide continued access to this medication for participants who have already been involved in previous studies of latozinemab. The goal is to further understand its effects and benefits for individuals with these conditions.

What is already known about the treatment

Latozinemab – Latozinemab is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its potential use in treating neurodegenerative diseases. The medication is designed to help manage symptoms associated with these conditions. At the molecular level, latozinemab works by targeting specific proteins involved in the progression of neurodegenerative diseases, aiming to slow down or alter the disease process. It is classified as a monoclonal antibody, a type of medication that specifically targets certain molecules in the body.

Investigated diseases

  • Alzheimer's Disease

    A progressive neurodegenerative disorder characterized by memory loss, cognitive decline, and behavioral changes. It typically begins with mild memory lapses and confusion, gradually worsening over time. As the disease advances, individuals may experience difficulty with language, disorientation, mood swings, and impaired reasoning. In later stages, individuals may lose the ability to carry out daily activities and require full-time care. The exact cause is not fully understood, but it involves the buildup of amyloid plaques and tau tangles in the brain. It is the most common cause of dementia among older adults.

  • Parkinson's Disease

    A chronic and progressive movement disorder resulting from the loss of dopamine-producing brain cells. It primarily affects motor skills, leading to symptoms such as tremors, stiffness, slowness of movement, and balance problems. Non-motor symptoms can also occur, including sleep disturbances, mood changes, and cognitive impairment. The progression of symptoms varies among individuals, and the disease can lead to significant disability over time. The exact cause is unknown, but it involves both genetic and environmental factors. It is the second most common neurodegenerative disorder after Alzheimer's disease.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506805-20-01Estimated enrolment52 patientsSponsorAlector LLC

sourced from the EU Clinical Trials Register and site verification

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