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Study on the Safety and Effects of DNL593 for Patients with Frontotemporal Dementia

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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 a condition known as Frontotemporal Dementia (FTD), which is a type of dementia that affects the frontal and temporal lobes of the brain, leading to changes in personality, behavior, and language. The study will evaluate a treatment called DNL593, which is a solution for injection developed by Denali Therapeutics Inc. The trial will also involve a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The purpose of the study is to assess the safety and tolerability of DNL593 in both healthy participants and those with Frontotemporal Dementia. The study is divided into several parts. Initially, healthy participants will receive a single dose of the treatment to evaluate its safety. Following this, participants with Frontotemporal Dementia will receive multiple doses over a period of up to 18 months. This will help researchers understand how the treatment works in the body and its potential effects on the disease.

Throughout the study, participants will be monitored for any side effects or changes in their health. This includes regular checks of vital signs, laboratory tests, and physical examinations. The study aims to gather important information about how DNL593 is processed in the body and its impact on the disease, which could lead to new insights and potential treatments for 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to ensure eligibility. This includes reviewing medical history and confirming any necessary criteria, such as age and health status.

  2. Step 2

    Part a: single dose administration

    Participants receive a single dose of the study medication, DNL593, administered intravenously. This phase is designed to evaluate the safety and tolerability of the medication in healthy individuals.

  3. Step 3

    Part b: multiple dose administration

    Participants with frontotemporal dementia receive multiple doses of DNL593. The medication is administered both orally and intravenously. This phase assesses the safety and tolerability of repeated doses.

  4. Step 4

    Part c: extended treatment

    Participants who complete Part B may continue to receive DNL593 for up to 18 months. This open-label extension phase further evaluates the long-term safety and effects of the medication.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to track health status. This includes laboratory tests, vital sign measurements, and physical examinations to ensure participant safety.

Who can join the trial?

11 criteria

  • For Part A:
    • Participants must be women who cannot have children (either because they have had surgery or are post-menopausal) or men.
    • Participants must be between the ages of 18 and 55 years.
    • Participants must have a Body Mass Index (BMI) between 18 and 32 kg/m². BMI is a measure of body fat based on height and weight.
    • If male participants engage in sex with a woman who can have children, both must use highly effective birth control methods.
    • For Part B:
      • Participants must be women who cannot have children (either because they have had surgery or are post-menopausal) or men. Women who can have children but are using highly effective birth control methods are also allowed.
      • Participants must be between the ages of 18 and 80 years.
      • Participants must have a Body Mass Index (BMI) between 18 and 32 kg/m².
      • Participants must have a Clinical Dementia Rating® plus National Alzheimer's Coordinating Center frontotemporal lobar degeneration global score of 0.5 or higher. This is a score used to assess the severity of dementia.
      • Participants must have a confirmed granulin (GRN) mutation through genetic testing or historical records.
      • If male participants engage in sex with a woman who can have children, both must use highly effective birth control methods.
      • For Part C:
        • Participants who completed Part B of this trial can join an 18-month extension if they have no unresolved significant side effects that could pose a risk to their safety.

Who cannot join the trial?

10 criteria

  • Participants cannot join if they have any medical condition other than Frontotemporal Dementia (FTD).
  • Participants must not have any other serious health issues that could interfere with the study.
  • Participants should not be taking any medication that might affect the study results.
  • Participants cannot be pregnant or breastfeeding.
  • Participants must not have a history of drug or alcohol abuse.
  • Participants should not have participated in another clinical trial recently.
  • Participants must not have any allergies to the study medication.
  • Participants should not have any mental health conditions that could affect their ability to participate.
  • Participants must not have any infections that could affect the study.
  • Participants should not have any neurological disorders other than FTD.
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Investigated drugs

DNL593 is a medication being studied to see if it is safe and well-tolerated by people. In this trial, researchers are looking at how the body handles DNL593 when given in single doses to healthy participants and in multiple doses to participants with a condition called Frontotemporal Dementia (FTD) with a specific genetic mutation known as FTD-GRN. The study aims to understand how DNL593 affects the body over time and whether it can be used safely in people with this type of dementia. Participants will receive DNL593 to help researchers learn more about its potential benefits and any possible side effects.

What is already known about the treatment

DNL593 – DNL593 is administered as an injection and is currently being studied in clinical trials to assess its safety and effectiveness. It is being investigated for its potential use in treating Frontotemporal Dementia (FTD), a condition that affects the brain and leads to changes in personality and behavior. The medication works by targeting specific proteins in the brain that are believed to contribute to the progression of FTD. DNL593 is classified as an investigational drug, meaning it is still under research and not yet approved for general medical use.

Investigated diseases

Frontotemporal Dementia (FTD) – Frontotemporal Dementia is a group of brain disorders caused by the degeneration of 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 comprehension. 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 I/IITrial ID2023-508697-28-00Protocol codeDNLI-H-0001Estimated enrolment69 patientsSponsorDenali Therapeutics Inc.

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