A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/Day for up to 12 Weeks) and to Explore the Effects on Potential Markers of Clinical Efficacy in Patient With Mild Cognitive Impairment

Trial Profile

A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/Day for up to 12 Weeks) and to Explore the Effects on Potential Markers of Clinical Efficacy in Patient With Mild Cognitive Impairment

Completed
Phase of Trial: Phase II

Latest Information Update: 03 Mar 2017

At a glance

  • Drugs CHF 5074 (Primary)
  • Indications Mild cognitive impairment
  • Focus Adverse reactions
  • Acronyms CT04-POLEP
  • Sponsors Chiesi Farmaceutici SpA; Chiesi USA
  • Most Recent Events

    • 01 Oct 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 26 Jul 2013 Interim data from the 90-week open-label extension study have been reported, according to a Chiesi Farmaceutici S.p.A. and CereSpir media release; 43 patients are expected to reach the 90-week endpoint at the end of 2013.
    • 26 Jul 2013 Interim analysis of cognitive tests of 30 patients reaching study week 88 published in a CereSpir media release.
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