Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
NCT05262023 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL593 in two parts followed by an optional open-label extension (OLE) period. Part A will evaluate the safety, tolerability, PK, and PD of single doses of DNL593 in healthy male and healthy female participants of nonchildbearing potential. Part B will evaluate the safety, tolerability, PK, and PD of multiple doses of DNL593 in participants with frontotemporal dementia (FTD) over 25 weeks. Part B will be followed by Part C, an optional 18-month OLE period available for all participants who complete Part B.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DNL593
Study Locations (20)
Other
- University of Antwerp — Antwerp
- UZ Leuven — Leuven
- L2IP - Instituto de Pesquisas Clinicas LTDA — Brasília
- Faculdade de Medicina Da Universidade de São Paulo — São Paulo
- Hospital Universitario San Ignacio — Bogotá
- Grupo de Neurosicencias de la Universidad de Antioquia — Medellín
- Fakultni nemocnice v Motole — Prague
- CHU de Nantes — Nantes
- CHU Rouen — Rouen
- CHU Toulouse — Toulouse
- ASST degli Spedali Civili di Brescia — Brescia
- Azienda Ospedaliera Universitaria Careggi — Florence
- IRCCS Istituto Auxologico Italiano — Milan
- Azienda Ospedaliera Cardinale G Panico — Tricase
- Erasmus University Medical Center — Rotterdam
- Hospital de Braga — Braga
- Campus Neurológico Sénior — Torres Vedras
California
- University of California San Francisco — San Francisco
Maryland
- John Hopkins University — Baltimore
Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2028-11 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05262023
The ClinicalTrials.gov registry entry for NCT05262023 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denali Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Frontotemporal Dementia appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05262023 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05262023 about?
NCT05262023 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)". This is a Phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL593 in two parts followed by an optional open-label extension (OLE) period. Part A will eval...
What is the current status of trial NCT05262023?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2022-02-01. Estimated completion is 2028-11.
What conditions does trial NCT05262023 study?
This clinical trial studies the following conditions: Frontotemporal Dementia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05262023?
The interventions under investigation include: Placebo (DRUG), DNL593 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05262023?
This trial is sponsored by Denali Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05262023 being conducted?
This trial has 20 study locations across California, Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.