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A Randomized, Double-blind, Placebo-controlled, Two-cohort, Parallel Group Study to Evaluate the Efficacy of CAD106 and CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Two-cohort, Parallel Group Study to Evaluate the Efficacy of CAD106 and CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 31 Oct 2019

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At a glance

  • Drugs Amilomotide (Primary) ; Umibecestat (Primary)
  • Indications Alzheimer's disease
  • Focus Therapeutic Use
  • Acronyms Generation S1
  • Sponsors Amgen; Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 11 Jul 2019 According to a Novartis media release, the study sponsors intend to further assess and present the data at a future scientific venue.
    • 11 Jul 2019 According to a Novartis media release, The study sponsors are informing investigators of the decision to discontinue the clinical program of CNP520 in Alzheimer's prevention, and advising that participants should stop taking the investigational treatment. The clinical investigators will contact participants to discuss what happens next, including follow-up appointments as appropriate.
    • 11 Jul 2019 Status changed from recruiting to discontinued. According to a Novartis media release, the company has announced the decision to discontinue investigation of CNP520 as an assessment of unblinded data during a regular pre-planned review identified worsening in some measures of cognitive function. Given these findings, the sponsors concluded that the potential benefit for participants in the studies did not outweigh the risk.
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