Lu AF20513
/ Lundbeck, Otsuka
- LARVOL DELTA
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February 23, 2020
Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD
(clinicaltrials.gov)
- P1; N=3; Terminated; Sponsor: H. Lundbeck A/S; Trial primary completion date: Mar 2019 ➔ Jun 2019
Trial primary completion date
November 29, 2019
Study to Evaluate the Safety and Tolerability of a New Drug Named Lu AF20513 in Patients With Mild Alzheimer's Disease
(clinicaltrials.gov)
- P1; N=50; Terminated; Sponsor: H. Lundbeck A/S; Trial primary completion date: Jan 2019 ➔ Jul 2019
Clinical • Trial primary completion date
November 21, 2019
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
(clinicaltrials.gov)
- P1; N=18; Terminated; Sponsor: H. Lundbeck A/S; Trial primary completion date: Feb 2019 ➔ May 2019
Clinical • Trial primary completion date
July 17, 2019
Study to Evaluate the Safety and Tolerability of a New Drug Named Lu AF20513 in Patients With Mild Alzheimer's Disease
(clinicaltrials.gov)
- P1; N=50; Terminated; Sponsor: H. Lundbeck A/S; Trial completion date: Dec 2019 ➔ Jul 2019; Active, not recruiting ➔ Terminated; Trial primary completion date: Oct 2019 ➔ Jan 2019; New data: The study was terminated based on new efficacy data from another study
Clinical • Trial completion date • Trial primary completion date • Trial termination
July 17, 2019
Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD
(clinicaltrials.gov)
- P1; N=3; Terminated; Sponsor: H. Lundbeck A/S; N=28 ➔ 3; Trial completion date: Dec 2019 ➔ Jun 2019; Active, not recruiting ➔ Terminated; Trial primary completion date: Dec 2019 ➔ Mar 2019; New data: The study was terminated based on new efficacy data from another study
Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination
June 12, 2019
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
(clinicaltrials.gov)
- P1; N=18; Terminated; Sponsor: H. Lundbeck A/S; Active, not recruiting ➔ Terminated; New data: The study was terminated based on new efficacy data from another study
Clinical • Trial termination
May 08, 2019
Product discontinued
(Lundbeck Press Release)
- Alzheimer's Disease
Discontinuation
May 08, 2019
Double-digit growth for all strategic brands and DKK 4,234 million in revenue and DKK 1,200 million in EBIT
(Lundbeck Press Release)
- "Lu AF20513 – phase I...It has been decided to discontinue the development project currently in phase I following increased uncertainty around the biological rationale. Lundbeck continues to be committed to developing treatments for Alzheimer’s."
Discontinuation
May 07, 2019
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
(clinicaltrials.gov)
- P1; N=18; Active, not recruiting; Sponsor: H. Lundbeck A/S; Enrolling by invitation ➔ Active, not recruiting; N=57 ➔ 18; Trial completion date: Feb 2022 ➔ May 2019; Trial primary completion date: Feb 2022 ➔ May 2019
Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date
May 07, 2019
Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD
(clinicaltrials.gov)
- P1; N=28; Active, not recruiting; Sponsor: H. Lundbeck A/S; Recruiting ➔ Active, not recruiting
Clinical • Enrollment closed
February 25, 2019
Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD
(clinicaltrials.gov)
- P1; N=28; Recruiting; Sponsor: H. Lundbeck A/S; Trial completion date: Jun 2019 ➔ Jan 2020; Trial primary completion date: Apr 2019 ➔ Jan 2020
Clinical • Trial completion date • Trial primary completion date
February 15, 2019
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
(clinicaltrials.gov)
- P1; N=57; Enrolling by invitation; Sponsor: H. Lundbeck A/S; Trial completion date: Nov 2020 ➔ Feb 2022; Trial primary completion date: Nov 2020 ➔ Feb 2022
Clinical • Trial completion date • Trial primary completion date
January 28, 2019
Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD
(clinicaltrials.gov)
- P1; N=28; Recruiting; Sponsor: H. Lundbeck A/S
Clinical • New P1 trial
January 10, 2019
IMMUNOLOGICAL AGENTS FOR NEUROCOGNITIVE DISORDERS- A REVIEW OF THE CURRENT EVIDENCE
(EPA 2019)
- "Finished trials with published Results were investigating a tau vaccine (AADvac 1- positive Results , phase 1 trial) and several vaccines directed against beta-amyloid plaques (ACC-001- negative Results , two phase 2A trials, gantenerumab- it may be efficient, but more trials are needed, bapineuzumab failed, phase 3 trial, BAN2401- it was efficient in a single phase 2A trial, AN1792- phase 2A trial produced positive effects and a follow-up after 4.6 years detected low anti-AN1792 antibody titers, and CAD106- only a phase 1 trial). The level of evidence for current immunological therapies targeting AD is not very encouraging, but many trials are currently ongoing or will start in near future."
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