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Joshua Grill, PhD

Positive topline results announced for TRAILBLAZER 3

By Carousel Slider, In the News, UCI MIND

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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A4 Study Releases Negative Results

By Carousel Slider, Commentary, In the News, UCI MIND

The topline results for the Anti-Amyloid treatment in Asymptomatic Alzheimer’s disease (A4) study were released today (https://a4study.org). Unfortunately, the drug being investigated, solanezumab, failed to demonstrate a benefit in slowing memory changes in a population of individuals age 65-to-85 who met criteria for preclinical Alzheimer’s disease. Preclinical Alzheimer’s is a relatively new construct. It includes people who are older and have normal memory performance, but in whom biological tests suggest that the risk for Alzheimer’s disease dementia is high. The A4 study was among the first ever preclinical AD trials, boldly blazing a trail that has now been followed by…

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No change in coverage yet for monoclonal antibody treatments for Alzheimer’s disease

By Carousel Slider, Commentary, In the News, UCI MIND

On February 17, 2023, a bipartisan group of Senators sent the Secretary of Health and Human Services, Javier Baccera, and the Administrator of the Centers for Medicare and Medicaid Services (CMS), Chiquita Brooks-LaSure, a letter requesting that CMS reconsider their decision to require Coverage with Evidence Determination (CED) that was levied after the accelerated approval of aducanumab. The letter followed a similar request from the Alzheimer’s Association, made in December 2022. The CED decision significantly limited access to aducanumab and other monoclonal antibodies (should they be approved), requiring that coverage would be granted only if Medicare beneficiaries were enrolled in…

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CTAD Abuzz

By Commentary, In the News, UCI MIND

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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Topline results announced for Phase 3 trial of gantenerumab

By Commentary, In the News, UCI MIND

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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Electronic medical records cannot deliver results with compassion

By Commentary, In the News, UCI MIND

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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Testing effective treatments as potential preventions

By Commentary, In the News, Participants, UCI MIND

Contributed by Joshua Grill, PhD Since Wednesday’s announcement by Eisai and Biogen of positive topline Phase 3 results for their treatment lecanemab in early Alzheimer’s disease, the field has been markedly aligned. Most agree that we need to see the data but that this seems to be a clear win and an important step in a positive direction. Some debates have begun, and more will happen, about the size and meaning of the win—that is, the size of the drug’s disease-slowing effects and the clinical meaningfulness. These debates will be extremely important but will take time. Combined with recently published…

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Eisai and Biogen announce positive Phase 3 results for lecanemab

By Commentary, In the News, UCI MIND

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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CMS Released Final Decision on Aduhelm

By Commentary, In the News, UCI MIND

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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