Skip to main content

DNLI-H-0001

A study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DNL593 in healthy participants and participants with Frontotemporal Dementia (FTD-GRN)

Sponsor
Denali Therapeutics Inc.
Phase
Drug
DNL593
Countries

Information about the drug that will be tested in the study

Administration

The drug will be administered via an intravenous infusion (an injection into the vein).

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

Participants with prodromal Alzheimer’s disease will be selected by chance to receive one of the following options:

  • An intravenous infusion of DNL593
  • An intravenous infusion of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect) for 24 weeks.)

Healthy participants will receive ascending single doses of either DNL593 or placebo. Participants with Frontotemporal Dementia will receive multiple doses of either DNL593 or placebo.

Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DNL593 in healthy participants and participants with Frontotemporal Dementia.

How long will the treatment last?;

The treatment lasts 25 weeks

Participants with Frontotemporal Dementia who will complete the trial will be eligible to enter an optional 18-month open-label extension period.

What will your involvement entail?
  • During the study, participants will be asked to complete some laboratory and biological tests to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
  • Participants will complete some other tests to measure blood pressure, heart rate and heart's rhythm (ECG)
  • Participants will be asked to perform lumbar punctures (CSF) to see changes in biomarkers in the brain
  • Complete a questionnaire about the suicidal ideation and behaviour (this is a test called Columbia-Suicide Severity Rating Scale - C-SSRS).

Further information on the procedures can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

  • Be between 18 and 80 years old
  • Have a body mass index (BMI) of ≥ 18 to ≤ 32 kg/m²
  • Use highly effective contraception
  • Women of non-childbearing potential (surgically sterilized or post-menopausal).

To take part in the study, participants with Frontotemporal Dementia must:

  • Have a score of ≥ 0.5 in the Clinical Dementia Rating® plus National Alzheimer's Coordinating Center frontotemporal lobar degeneration global score
  • Have confirmed granulin (GRN) mutation via genetic testing or historical records available.
Who cannot participate in the study?

Exclusion criteria include:

  • Presence of other significant neurological or psychiatric disorders
  • History of malignancy
  • History of stroke, cognitive impairment due to causes other than Frontotemporal Dementia
  • Have a positive serum pregnancy test or are currently lactating or breastfeeding.s

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study. 

Information for your doctor

EudraCT Number

2021-005733-16

Clinicaltrials.gov identifier

NCT05262023

Study contact information

Enrolmentservices@simbecorion.com

Link to full text

https://clinicaltrials.gov/ct2/show/NCT05262023

The information contained in this document is based on information available on public registries (e.g. clinical trials.gov website) on November 2022.

Click here to download the accessible easy-to-read version of this document

Attachments
Document
dnl593_denali.pdf (146.4 KB)
 
Acknowledgement

Alzheimer Europe's Clinical Trials Watch database was developed as part of the 2018 Work Plan which received funding under an operating grant from the European Union’s Health Programme (2014–2020).

Alzheimer Europe gratefully acknowledges the support of its corporate sponsors for the update and maintenance of the database.

Image