Joshua Grill, PhD

Contributed by Joshua Grill, PhD On the opening night of the Clinical Trials for Alzheimer’s Disease (CTAD) meeting, a packed room was abuzz with excitement. The evening included five presentations related to the Phase 3 CLARITY-AD trial of lecanemab, a monoclonal antibody against the beta amyloid protein that builds up in the brain of a person with Alzheimer’s disease. The excitement and anticipation were palpable, since the sponsor of the trial, Eisai, had announced in September that the results were positive. The presentations were accompanied by the full publication of the results in the New England Journal of Medicine and coverage…

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Contributed by Joshua Grill, PhD On November 14, Roche announced negative topline results for their GRADUATE program testing gantenerumab, a monoclonal antibody against the beta amyloid protein that accumulates in the brain of people with Alzheimer’s disease. The program included two phase 3 trials (GRADUATE 1 and GRADUATE 2). As with other recent trials, the studies included patients with “early Alzheimer’s disease,” including people with Mild Cognitive Impairment and mild dementia. The trials were large and lengthy, with 1965 participants (across the two studies) who were followed for 27 months. According to the press release, participants randomized to gantenerumab demonstrated…

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Contributed by Joshua Grill, PhD An article in the October 3 New York Times highlights recent developments in providing patients legal access to their medical records. Brought about by the 21St Century Cures Act, this effort aims to remove barriers to citizens having access to their own health data. Implementation of the 21St Century Cures Act essentially mandates that medical test results be made available through electronic health records in near real time, giving patients access almost immediately to their health information without context. This is producing challenges for clinicians and their practices. Some of these challenges were highlighted in…

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Contributed by Joshua Grill, PhD Today, Eisai and Biogen announced that the topline results of their Phase 3 trial, known as CLARITY, were positive. CLARITY was a placebo-controlled double-blind study of the monoclonal antibody against the amyloid beta protein lecanemab in patients with Mild Cognitive Impairment or mild dementia due to Alzheimer’s disease. Lecanemab has been shown previously to reduce amyloid burden in the brain of patients with symptomatic Alzheimer’s disease. According to today’s press release, lecanemab was effective in slowing decline measured with the Clinical Dementia Rating Scale (CDR), compared to placebo. This scale has been suggested by the…

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Contributed by Joshua Grill, PhD: The Centers for Medicaid and Medicare Services (CMS) recently released their final decision related to coverage for the monoclonal antibody against beta amyloid, aducanumab (Aduhelm®). The decision was expected by many and includes only a few changes from the preliminary decision announced January 11. The decision remains that CMS will pay for aducanumab under a coverage with evidence determination (CED). This means that the drug will only be covered when a person with Mild Cognitive Impairment or mild dementia is enrolled in a randomized controlled trial. Such trials will need to be approved by CMS…

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