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It could be years before Biogen completes its confirmatory trial for its controversial new Alzheimer’s drug, Aduhelm (up to nine years, to be precise). But in the meantime, the company is launching a real-world Phase IV study to assess the drug’s long-term effects – this time, with a focus on recruiting more patients from minority groups.
Biogen and Eisai are seeking 6,000 Alzheimer’s disease patients with mild cognitive impairment or mild dementia to participate in an observational study dubbed ICARE AD-US, the partners shared Thursday at the Alzheimer’s Association international conference . After taking Aduhelm, study patients will be monitored approximately every six months for a total of five years, as researchers look for changes in cognition, function, and neuropsychiatric status.
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