Joshua Grill, PhD

On Friday October 13, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a formal change to their coverage policy for amyloid PET imaging. Previously, with limited exceptions, patients were required to be enrolled in a clinical study known as “Coverage with Evidence Determination” for the scan to be reimbursed. Now, that requirement has been removed and the door has been opened for more patients to get the scan and result in savings of thousands of dollars for patients and their families. In fact, patients may have the opportunity to receive multiple covered scans as part of their routine care…

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Results were presented on Monday from the first-of-its kind Anti-Amyloid treatment in Asymptomatic Alzheimer’s (A4) Study. The A4 was a more than 10-year project to conduct one of the first and largest “preclinical” Alzheimer’s disease clinical trials, testing a compound for potential disease-slowing properties before memory problems begin in a population deemed at risk based on an amyloid PET scan biomarker test. Unfortunately, the drug studied, solanezumab, did not slow memory worsening compared to placebo in this trial. This was surprising given the previous findings in which solanezumab had appeared to have very small but seemingly real effects in symptomatic…

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Results were presented on Monday for TRAILBLAZER-ALZ-2, a registration trial of the monoclonal antibody donanemab, which was previously announced as positive. The data were highly convincing that donanemab has a significant effect of slowing disease progression in Alzheimer’s disease and almost certainly points to a full clinical approval for the drug by the FDA in the future. The primary analytic group under study in this TRAILBLAZER study (there are several different clinical trials of donanemab sponsored by Eil Lilly under the moniker of “TRAILBLAZER”) was patients with “low-to-medium tau burden,” assessed with a tau PET scan. Unlike the previous trial…

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July 6, 2023—Today, the US Food and Drug Administration granted full approval to the drug lecanemab (brand name Leqembi®), a monoclonal antibody that has been demonstrated to lower levels of amyloid plaques in the brain and slow cognitive and functional decline in people living with Mild Cognitive Impairment and mild dementia due to Alzheimer’s disease. The approval is the first full approval of a new drug for Alzheimer’s disease in nearly 2 decades. The full, or traditional, approval is distinguished from “accelerated” approval, which lecanemab was also granted in January of this year. The full approval communicates that the agency…

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On June 9, The US Food and Drug Administration convened members of the updated Peripheral and Central Nervous System Drugs Advisory Committee to review the available data for lecanemab, the monoclonal antibody treatment for early Alzheimer’s disease developed by Eisai and Biogen. The members voted unanimously, 6-0, in favor of approval. Lecanemab was recently granted accelerated approval by FDA, based on demonstration that treatment with the infused medication could lower brain amyloid levels (https://mind.uci.edu/fda-grants-accelerated-approval-to-lecanemab/). Based on results from a large Phase 3 trial in which lecanemab demonstrated efficacy in slowing disease progression over 18-months (https://mind.uci.edu/eisai-and-biogen-announce-positive-phase-3-results-for-lecanemab/), the agency will now consider full…

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May 3, 2023–Eli Lilly and company announced today (https://investor.lilly.com/news-releases/news-release-details/lillys-donanemab-significantly-slowed-cognitive-and-functional) the positive topline results from their Phase 3 clinical trial of donanemab, a monoclonal antibody that rapidly lowers beta amyloid levels in the brain of people with Alzheimer’s disease. The release indicated that patients treated with donanemab experienced significantly slower cognitive and functional decline, compared to those receiving placebo, over 18 months. The primary outcome was a composite measure known as the integrated Alzheimer’s Disease Rating Scale (iADRS, a tool that borrows pieces of other instruments to look at elements key in early disease) and was reported as demonstrating a 35%…

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