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NCT03757325
Study to Evaluate DNL747 in Subjects With Alzheimer's Disease
Phase 1 trial testing DNL747 in Alzheimer Disease in 16 participants. Completed in 5 December 2019.
5 December 2019
Quick facts
| Lead sponsor | Denali Therapeutics Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 13 February 2019 |
| Primary completion | 5 December 2019 |
| Estimated completion | 5 December 2019 |
| Sites | 5 locations across Netherlands, United States |
Drugs / interventions tested
- DNL747 — full drug profile →
- Placebo
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
Sponsor
Denali Therapeutics Inc. — full company profile →
Who can join
Adults 55 to 85, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL747 in subjects with Alzheimer's disease when administered for 29 days in a cross-over design
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Molecular mechanisms of cell death in neurological diseases.
Moujalled D, Strasser A, Liddell JR. · · 2021 · cited 513× · PMID 34099897 · DOI 10.1038/s41418-021-00814-y -
Alzheimer's disease drug development pipeline: 2019.
Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008 -
Receptor-interacting protein kinase 1 (RIPK1) as a therapeutic target.
Mifflin L, Ofengeim D, Yuan J. · · 2020 · cited 350× · PMID 32669658 · DOI 10.1038/s41573-020-0071-y -
Mitochondria-associated programmed cell death as a therapeutic target for age-related disease.
Nguyen TT, Wei S, Nguyen TH, Jo Y, et al · · 2023 · cited 221× · PMID 37612409 · DOI 10.1038/s12276-023-01046-5 -
Molecular Insights into the Mechanism of Necroptosis: The Necrosome As a Potential Therapeutic Target.
Chen J, Kos R, Garssen J, Redegeld F. · · 2019 · cited 135× · PMID 31766571 · DOI 10.3390/cells8121486 -
Cell Death and Neurodegeneration.
Andreone BJ, Larhammar M, Lewcock JW. · · 2020 · cited 85× · PMID 31451511 · DOI 10.1101/cshperspect.a036434 -
Safety, pharmacokinetics and target engagement of novel RIPK1 inhibitor SAR443060 (DNL747) for neurodegenerative disorders: Randomized, placebo-controlled, double-blind phase I/Ib studies in healthy subjects and patients.
Vissers MFJM, Heuberger JAAC, Groeneveld GJ, Oude Nijhuis J, et al · · 2022 · cited 70× · PMID 35649245 · DOI 10.1111/cts.13317 -
RIPK protein kinase family: Atypical lives of typical kinases.
Cuny GD, Degterev A. · · 2021 · cited 68× · PMID 32732131 · DOI 10.1016/j.semcdb.2020.06.014
Verify or expand the search:
- PubMed search for NCT03757325
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of DNL747
Trials testing the same drug.
- NCT03757351 — Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral Sclerosis · Phase 1 · terminated
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Currently open trials in the same condition.
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Other Denali Therapeutics Inc. trials
Trials by the same sponsor.
- NCT06602193 — Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD) · Phase 2 · recruiting
- NCT06281158 — A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in · Phase 1 · completed
- NCT05450549 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants · Phase 1 · completed
- NCT05006352 — A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Later · Phase 1 · completed
- NCT04581772 — A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03757325 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Denali Therapeutics Inc.
- Last refreshed: 26 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03757325.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing