EMERGE/ENGAGE Trial of Early AD Therapy Launches at 3 Cleveland Clinic Sites

Phase 3 study of aducanumab enrolling in Las Vegas, Ohio, Florida

Cleveland Clinic Lou Ruvo Center for Brain Health is enrolling individuals at its Las Vegas, Cleveland and Florida (Weston) sites for participation in a phase 3, multicenter study of a new therapy for early Alzheimer disease (AD).

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The global trial — which is known as EMERGE in roughly half its study sites and as ENGAGE in the other half — is assessing the investigational monoclonal antibody aducanumab (BIIB037) for efficacy and safety in slowing cognitive and functional impairment in patients with mild cognitive impairment or early AD. The compound has been shown to reduce brain amyloid plaque levels in preclinical and phase 1 studies.

Candidates for the EMERGE/ENGAGE trial include men and women ages 50 to 85 who have mild cognitive impairment or early AD, have a reliable caregiver and meet the following key inclusion criteria:

  • A positive amyloid PET scan
  • Objective evidence of cognitive impairment at screening

The investigation is sponsored by Biogen (developer of aducanumab) and is expected to enroll 1,350 patients in total. It employs a double-blind design in which enrollees are randomized to receive monthly infusions of aducanumab or placebo for 78 weeks. Two patients will receive active drug for every one patient assigned to placebo.

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Enrollees will undergo the periodic assessment with the following:

  • Interviews and questionnaires to assess cognition, feelings and function
  • Physical examinations
  • MRI and PET imaging

Data collection is expected to be completed by early 2020.

“We are very excited to add the EMERGE/ENGAGE study to the extensive list of clinical trials for AD that we offer at our multiple Cleveland Clinic sites,” says Kate Zhong, MD, Senior Director of Clinical Research at Cleveland Clinic Lou Ruvo Center for Brain Health, who practices in Las Vegas. “With every trial conducted, we come one step closer to our ultimate goal of finding a cure.”

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To refer a patient for enrollment in EMERGE (Las Vegas area), call 702.483.6000 or 702.701.7893; to refer for enrollment in ENGAGE (Cleveland and Weston, Florida, areas), call 216.445.9009.