Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)

Next Previous
Trial Profile

A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 07 Nov 2022

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Donepezil (Primary)
  • Indications Lewy body disease
  • Focus Therapeutic Use
  • Sponsors Eisai Co Ltd

Most Recent Events

  • 01 Nov 2022 According to Eisia media release, treatment with this drug showed a trend toward improvement in cognitive function, and this result is consistent with the results of the clinical trial at the time of approval of the drug; Therefore, it was concluded that the approved label (dose and administration) and package insert should be appropriately revised (Category 2). The condition of the approval was lifted as of the date of receipt of the reexamination results.
  • 01 Nov 2022 According to Eisia media release, the reexamination based on postmarketing studies, including the results of Study 419, stated that at present, the evaluation of clinical function in DLB using CIBIC-Plus is not always sufficiently established as an evaluation method, and it is difficult to comprehensively evaluate the efficacy of this drug for DLB, although efficacy was seen in some patients.
  • 01 Nov 2022 Primary endpoint (Clinicians Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)) has not been met as per Eisai Media Release

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top