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Lilly says Alzheimer's drug slows clinical decline in mid-stage trial

Discussion in 'Other health news and research' started by Jaybee00, Jan 11, 2021.

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  1. Jaybee00

    Jaybee00 Senior Member (Voting Rights)

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  2. Trish

    Trish Moderator Staff Member

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    It looks like there are lots of articles being produced on the basis of a press release by the drug company. I can't find a published trial.

    There is this trial currently under way:
    https://clinicaltrials.gov/ct2/show/NCT04437511

     
  3. akrasia

    akrasia Established Member (Voting Rights)

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    I posted this around Christmas but I have a feeling it was lost in the usual late December distraction, this year made even more intense by Covid.

    https://www.s4me.info/threads/an-hour-of-light-and-sound-a-day-might-keep-alzheimer%E2%80%99s-at-bay.8614/#post-311780


    post 13

    There have been so many false dawns in Alzheimer’s research and because it has its stink eye on me, I’ve followed it for almost a couple of decades. Will gamma 40hz lead somewhere, we’ll see. But for the first time, I see a glimmer of hope.
     
    alktipping likes this.
  4. John Mac

    John Mac Senior Member (Voting Rights)

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    Study now published

    https://jamanetwork.com/journals/ja...ign=ftm_links&utm_content=tfl&utm_term=071723

    Key Points

    Question Does donanemab, a monoclonal antibody designed to clear brain amyloid plaque, provide clinical benefit in early symptomatic Alzheimer disease?

    Findings In this randomized clinical trial that included 1736 participants with early symptomatic Alzheimer disease and amyloid and tau pathology, the least-squares mean change in the integrated Alzheimer Disease Rating Scale score (range, 0-144; lower score indicates greater impairment) at 76 weeks was −6.02 in the donanemab group and −9.27 in the placebo group for the low/medium tau population and −10.19 in the donanemab group and −13.11 in the placebo group in the combined study population, both of which were significant differences.

    Meaning Among participants with early symptomatic Alzheimer disease and amyloid and tau pathology, donanemab treatment significantly slowed clinical progression at 76 weeks.

    Abstract
    Importance There are limited efficacious treatments for Alzheimer disease.

    Objective To assess efficacy and adverse events of donanemab, an antibody designed to clear brain amyloid plaque.

    Design, Setting, and Participants Multicenter (277 medical research centers/hospitals in 8 countries), randomized, double-blind, placebo-controlled, 18-month phase 3 trial that enrolled 1736 participants with early symptomatic Alzheimer disease (mild cognitive impairment/mild dementia) with amyloid and low/medium or high tau pathology based on positron emission tomography imaging from June 2020 to November 2021 (last patient visit for primary outcome in April 2023).

    Interventions Participants were randomized in a 1:1 ratio to receive donanemab (n = 860) or placebo (n = 876) intravenously every 4 weeks for 72 weeks. Participants in the donanemab group were switched to receive placebo in a blinded manner if dose completion criteria were met.

    Main Outcomes and Measures The primary outcome was change in integrated Alzheimer Disease Rating Scale (iADRS) score from baseline to 76 weeks (range, 0-144; lower scores indicate greater impairment). There were 24 gated outcomes (primary, secondary, and exploratory), including the secondary outcome of change in the sum of boxes of the Clinical Dementia Rating Scale (CDR-SB) score (range, 0-18; higher scores indicate greater impairment). Statistical testing allocated α of .04 to testing low/medium tau population outcomes, with the remainder (.01) for combined population outcomes.

    Results Among 1736 randomized participants (mean age, 73.0 years; 996 [57.4%] women; 1182 [68.1%] with low/medium tau pathology and 552 [31.8%] with high tau pathology), 1320 (76%) completed the trial. Of the 24 gated outcomes, 23 were statistically significant. The least-squares mean (LSM) change in iADRS score at 76 weeks was −6.02 (95% CI, −7.01 to −5.03) in the donanemab group and −9.27 (95% CI, −10.23 to −8.31) in the placebo group (difference, 3.25 [95% CI, 1.88-4.62]; P < .001) in the low/medium tau population and −10.2 (95% CI, −11.22 to −9.16) with donanemab and −13.1 (95% CI, −14.10 to −12.13) with placebo (difference, 2.92 [95% CI, 1.51-4.33]; P < .001) in the combined population. LSM change in CDR-SB score at 76 weeks was 1.20 (95% CI, 1.00-1.41) with donanemab and 1.88 (95% CI, 1.68-2.08) with placebo (difference, −0.67 [95% CI, −0.95 to −0.40]; P < .001) in the low/medium tau population and 1.72 (95% CI, 1.53-1.91) with donanemab and 2.42 (95% CI, 2.24-2.60) with placebo (difference, −0.7 [95% CI, −0.95 to −0.45]; P < .001) in the combined population. Amyloid-related imaging abnormalities of edema or effusion occurred in 205 participants (24.0%; 52 symptomatic) in the donanemab group and 18 (2.1%; 0 symptomatic during study) in the placebo group and infusion-related reactions occurred in 74 participants (8.7%) with donanemab and 4 (0.5%) with placebo. Three deaths in the donanemab group and 1 in the placebo group were considered treatment related.

    Conclusions and Relevance Among participants with early symptomatic Alzheimer disease and amyloid and tau pathology, donanemab significantly slowed clinical progression at 76 weeks in those with low/medium tau and in the combined low/medium and high tau pathology population.
     
    mango and Jaybee00 like this.
  5. John Mac

    John Mac Senior Member (Voting Rights)

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    BBC news coverage of the study

    https://www.bbc.co.uk/news/health-66221116

    Results out today confirm that the drug donanemab, hailed as a turning point in the fight against Alzheimer's, slows cognitive decline by about a third.

    Mike Colley, who is 80, is one of only a few dozen patients in the UK to take part in the global trial, now published in the journal JAMA.

    He gets an infusion each month at a clinic in London and says he is "one of the luckiest people you'll ever meet".

    The antibody treatment helps in the early stages of the disease.

    It works in Alzheimer's disease, not in other types of dementia, such as vascular dementia.
     
  6. cassava7

    cassava7 Senior Member (Voting Rights)

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    Is 3 points on the 144 point iARDS scale a clinicially meaningful difference? With a 11-fold higher risk of edema and 18.5-fold risk of injection-related reaction, donanemab cannot be said to have a positive benefit-to-risk ratio.

    If the drug goes on approved by any health authority, this would indicate a serious problem with the evaluation of the evidence.
     
    Trish, chillier, Sid and 1 other person like this.
  7. Sid

    Sid Senior Member (Voting Rights)

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    Another scam.
     
  8. Shadrach Loom

    Shadrach Loom Senior Member (Voting Rights)

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    Hardly a “scam”, although the PR campaign is pretty transparent.

    I imagine that every iARDS point cashes out as competencies and signs of engagement that would feel very meaningful to a person with Alzheimers and to their family. I’m not familiar with the scale, but I’ve definitely seen the impact of those incremental changes.

    Whether this drug and the requisite kit is going to be affordable for broken public health systems is moot, though.
     
    Last edited: Jul 18, 2023
    NelliePledge likes this.
  9. Trish

    Trish Moderator Staff Member

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    Newspaper headlines in at least 2 UK papers today say the drug slows development of dementia by 'up to 60%'. Surely that's misleading exaggeration, and presumably must have come from a press statement from the researchers or the drug company.
     
    shak8 and RedFox like this.

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