Trial Profile
A Placebo-Controlled, Double-Blind, Parallel-Group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study With an Open-Label Extension Phase to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease
Status:
Active, no longer recruiting
Phase of Trial:
Phase II
Latest Information Update: 16 Apr 2024
Price :
$35
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At a glance
- Drugs Lecanemab (Primary)
- Indications Alzheimer's disease; Dementia; Mild cognitive impairment
- Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
- Acronyms CLARITY-AD
- Sponsors Biogen; Eisai Co Ltd; Eisai Inc
- 12 Apr 2024 According to an Eisai Co Ltd media release, findings from this study will be presented at the American Academy of Neurology (AAN) Annual Meeting held in Denver, Colorado, and virtually from April 13-18, 2024.
- 01 Apr 2024 According to a Eisai Co Ltd Media Release, the company aimed to submit a Biologics License Application (BLA) for weekly maintenance therapy using subcutaneous (SC) administration in March 2024. for which FDA said Fast Track designation specific for the SC formulation is needed to receive rolling review for which company submitted a request for Fast Track designation for the SC formulation and will initiate a rolling submission which will be given within 60 days from the March 2024 submission.
- 01 Apr 2024 According to a Eisai Co Ltd Media Release, the company Completes Submission of LEQEMBI (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimers Disease to the U.S. FDA.sBLA is based on modeling of observed data from the Phase 2 study (Study 201) and its open-label extension (OLE) as well as Clarity AD study (Study 301) and its OLE study.