A Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Simultaneously Qualify a Biomarker Algorithm for Prognosis of Risk of Developing Mild Cognitive Impairment Due to Alzheimer's Disease (MCI Due to AD) and to Test the Safety and Efficacy of Pioglitazone (AD-4833 SR 0.8 mg QD) to Delay the Onset of MCI Due to AD in Cognitively Normal Subjects

Trial Profile

A Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Simultaneously Qualify a Biomarker Algorithm for Prognosis of Risk of Developing Mild Cognitive Impairment Due to Alzheimer's Disease (MCI Due to AD) and to Test the Safety and Efficacy of Pioglitazone (AD-4833 SR 0.8 mg QD) to Delay the Onset of MCI Due to AD in Cognitively Normal Subjects

Discontinued
Phase of Trial: Phase III

Latest Information Update: 04 May 2018

At a glance

  • Drugs Pioglitazone (Primary)
  • Indications Alzheimer's disease; Mild cognitive impairment
  • Focus Registrational; Therapeutic Use
  • Acronyms TOMMORROW
  • Sponsors Takeda
  • Most Recent Events

    • 25 Jan 2018 According to a Takeda media release, results from the study will be presented at a future scientific meeting.
    • 25 Jan 2018 According to a Takeda media release, the company will further analyze data from the trial, including the performance of the genetic-based biomarker risk assignment algorithm, with the hope that this information may ultimately help in the global fight against Alzheimer's disease.
    • 25 Jan 2018 Status changed from active, no longer recruiting to discontinued, based on a planned interim futility analysis, which showed an inadequate treatment effect with the investigational drug pioglitazone 0.8 mg SR in delaying the onset of mild cognitive impairment (MCI) due to Alzheimer's disease (AD), as reported in a Takeda media release.
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