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NCT03668405
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
Phase 1 trial testing Lu AF20513 in Alzheimer's Disease in 18 participants. Terminated before completion.
27 May 2019
Quick facts
| Lead sponsor | H. Lundbeck A/S |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 26 June 2018 |
| Primary completion | 27 May 2019 |
| Estimated completion | 27 May 2019 |
| Sites | 4 locations across Sweden, Finland |
Drugs / interventions tested
- Lu AF20513 — full drug profile →
Conditions studied
- Alzheimer's Disease — all drugs for Alzheimer's Disease →
Sponsor
H. Lundbeck A/S — full company profile →
Who can join
Adults 60 to 85, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the long-term safety, tolerability and antibody response of Lu AF20513 in patients with Alzheimer's disease who have completed the 16026A study.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Detection and treatment of Alzheimer's disease in its preclinical stage.
Rafii MS, Aisen PS. · · 2023 · cited 104× · PMID 37202518 · DOI 10.1038/s43587-023-00410-4 -
Roles and Mechanisms of the Protein Quality Control System in Alzheimer's Disease.
Liu Y, Ding R, Xu Z, Xue Y, et al · · 2021 · cited 16× · PMID 35008771 · DOI 10.3390/ijms23010345 -
Biologics as Therapeutical Agents Under Perspective Clinical Studies for Alzheimer's Disease.
Li H, Shen X, Zhang B, Zhu Z. · · 2025 · cited 7× · PMID 40942007 · DOI 10.3390/molecules30173479 -
Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497
Verify or expand the search:
- PubMed search for NCT03668405
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lu AF20513
Trials testing the same drug.
- NCT03819699 — Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD · Phase 1 · terminated
Other recruiting trials for Alzheimer's Disease
Currently open trials in the same condition.
- NCT07457138 — Lombard Cohort of Brain Health Services · recruiting
- NCT07234942 — A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants Wit · Phase 1 · recruiting
- NCT07479914 — Art of Memory for Cognitive Enhancement in the Monza Brain Health Service · NA · active not recruiting
- NCT07214727 — A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease · Phase 1 · recruiting
- NCT07105709 — Open-label Extension Study in Participants With Early Alzheimer's Disease · Phase 2 · recruiting
Other H. Lundbeck A/S trials
Trials by the same sponsor.
- NCT07514858 — A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations · Phase 2 · not yet recruiting
- NCT07513441 — A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD) · Phase 1 · not yet recruiting
- NCT06701526 — A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications · Phase 4 · active not recruiting
- NCT06706622 — A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA) · Phase 3 · active not recruiting
- NCT06557850 — A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease · Phase 1 · active not recruiting
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 NCT03668405 (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 H. Lundbeck A/S
- Last refreshed: 21 November 2019
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/NCT03668405.
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