Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05262023 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
A Phase 1 study of Frontotemporal Dementia, sponsored by Denali Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
- 20
- Study locations
NCT05262023 is a Phase 1 study of Frontotemporal Dementia that is active but no longer recruiting, run by Denali Therapeutics. The registered enrollment target is 85 participants, below the 1,194-participant average among 22 other Frontotemporal Dementia trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT05262023, a Phase 1 study of Frontotemporal Dementia, is active but no longer recruiting, sponsored by Denali Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
- 20
- Study locations
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?
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, categorized as Phase 1. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,194-participant average among 22 other Frontotemporal Dementia trials with a reported enrollment target (93% lower). The listed sponsor is Denali Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.
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.
NCT05262023 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Other, California, Maryland.
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.
What interventions are being tested in trial NCT05262023?
The interventions under investigation include: Placebo (DRUG), DNL593 (DRUG).
Who is sponsoring clinical trial NCT05262023?
This trial is sponsored by Denali Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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
Similar trials for Frontotemporal Dementia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Evaluate the Safety and Effect of AVB-101, a Gene Therapy Product, in Subjects With a Genetic Sub-type of Frontotemporal Dementia (FTD-GRN)
RECRUITING · Phase 1
-
First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Dementia
RECRUITING · Phase 1
-
A Study of PBFT02 in Participants With FTD and Mutations in the Granulin Precursor (GRN) or C9ORF72 Genes
RECRUITING · Phase 1
-
Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)
ACTIVE NOT RECRUITING · Phase 1
-
A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation
COMPLETED · Phase 1
-
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.