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

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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 Frontotemporal Dementia (FTD), a condition that affects the brain and can lead to changes in behavior and personality, as well as difficulties with language and movement. The study is testing a treatment called latozinemab, also known by its code name AL001. This treatment is given as a solution through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of the study is to evaluate how effective and safe AL001 is for individuals who are at risk for or have FTD due to specific genetic changes, known as heterozygous mutations in the progranulin gene.

Participants in the study will be randomly assigned to receive either the AL001 treatment or a placebo, which is a sterile solution that looks like the treatment but does not contain the active substance. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations or bias. The study will take place over a period of time, with participants receiving the treatment or placebo and undergoing regular assessments to monitor their condition and any changes that occur.

The trial aims to measure changes in participants' symptoms and overall condition at various points during the study, specifically at weeks 48, 72, and 96. These assessments will help determine the effectiveness of AL001 in managing the symptoms of FTD and its impact on participants' quality of life. The study will also monitor the safety of the treatment to ensure that it does not cause any harmful side effects. By participating in this trial, researchers hope to gather valuable information that could lead to better treatment options for individuals affected by Frontotemporal Dementia.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either the study medication, latozinemab, or a placebo. A placebo is a sterile solution that looks like the study medication but does not contain the active ingredient.

    The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving to ensure unbiased results.

  2. Step 2

    Treatment administration

    You will receive the treatment through an intravenous infusion. This means the solution will be administered directly into your vein using a needle.

    The frequency and dosage of the treatment will be determined by the study protocol, and you will be informed about the schedule during your visits.

  3. Step 3

    Regular assessments

    Throughout the study, you will undergo regular assessments to monitor your health and the effects of the treatment. These assessments will include evaluations of your cognitive and functional abilities.

    The primary goal is to measure changes from the start of the study to weeks 48, 72, and 96 using specific scales designed to assess dementia symptoms.

  4. Step 4

    Study partner involvement

    A study partner, someone who knows you well and can provide information about your behavior and abilities, will be required to accompany you to certain visits.

    The study partner will help provide accurate information to the study team and ensure that the assessments are completed effectively.

  5. Step 5

    Completion of the study

    The study is expected to last until 2026, with regular check-ins and assessments throughout this period.

    Upon completion, you will have contributed valuable information that may help in understanding and treating frontotemporal dementia.

Who can join the trial?

8 criteria

  • The patient must have a known genetic change called a heterozygous loss-of-function GRN mutation that causes frontotemporal dementia (FTD).
  • The patient must be between the ages of 25 and 85 years old.
  • Women must not be pregnant or breastfeeding. They must either be unable to become pregnant or agree to use birth control during the study and for 10 weeks after the last dose of the study treatment.
  • Men must agree to use birth control and not donate sperm during the study and for 10 weeks after the last dose of the study treatment.
  • The patient must agree not to donate blood or blood products during the study and for one year after the final dose of the study treatment.
  • The patient must be willing and able to follow the study rules and requirements.
  • The patient must be able to give informed consent, or if not, a legally authorized representative must provide consent on their behalf, and the patient must agree to participate.
  • The patient must have a study partner who knows them well, spends at least 5 hours per week with them, and can provide information about their behavior, thinking, and daily activities. The study partner must also agree to participate in the study and attend certain visits.

Who cannot join the trial?

8 criteria

  • Patients with any other type of dementia besides Frontotemporal dementia (FTD) cannot participate. Dementia is a condition that affects memory and thinking skills.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period cannot participate. Surgery is a medical procedure to treat or diagnose a condition.
  • Patients with a history of severe allergic reactions to medications cannot participate. Allergic reactions are when the body reacts badly to something, like a medicine.
  • Patients who are currently participating in another clinical trial cannot participate. A clinical trial is a research study to test new treatments.
  • Patients with unstable or serious medical conditions that could interfere with the study cannot participate. This means any health problem that is not well-controlled or could cause complications.
  • Patients who are pregnant or breastfeeding cannot participate. Pregnant means expecting a baby, and breastfeeding means feeding a baby with milk from the breast.
  • Patients with a history of drug or alcohol abuse within the past year cannot participate. Abuse means using too much of a substance in a way that is harmful.
  • Patients who have a mental health condition that could interfere with the study cannot participate. Mental health conditions affect mood, thinking, and behavior.
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Investigated drugs

AL001 is a medication being studied for its potential to help people who are at risk for or already have a condition called frontotemporal dementia. This condition is linked to changes in a specific gene known as the progranulin gene. The medication is being tested to see if it can improve symptoms or slow down the progression of the disease. The study is designed to compare the effects of AL001 with a placebo, which is a substance with no active ingredients, to determine how effective AL001 is in treating this form of dementia.

What is already known about the treatment

AL001 – AL001 is administered orally in the form of a pill and is currently being studied in clinical trials for its potential use in treating frontotemporal dementia (FTD), particularly in individuals with specific genetic mutations. This medication is still under investigation, and its effectiveness and safety are being evaluated in a Phase 3 clinical trial. AL001 is designed to help manage symptoms of FTD by targeting and modifying certain biological pathways associated with the disease. It falls under the category of investigational drugs, meaning it is not yet approved for general medical use.

Investigated diseases

Frontotemporal dementia (FTD) – Frontotemporal dementia is a group of brain disorders caused by the progressive loss of nerve cells in the frontal and temporal lobes of the brain. This degeneration leads to changes in personality, behavior, and language. As the disease progresses, individuals may experience increasing difficulty with speech and understanding language. Emotional responses and social behavior can become inappropriate or impulsive. Over time, the ability to perform daily activities independently diminishes. The progression of symptoms varies among individuals, but it generally leads to significant impairment in social and occupational functioning.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506873-36-00Estimated enrolment119 patientsSponsorAlector LLC

sourced from the EU Clinical Trials Register and site verification

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