Moreover, physicians should rule out other causes for cognitive impairment, including side effects of medication, folate or vitamin B12 deficiencies, vascular dementia, or normal pressure hydrocephalus. The panel urged that anyone who has cerebral amyloid angiopathy, a blood clotting disorder, or takes anticoagulants should not be on aducanumab, because they are already at higher risk for the brain swelling and microhemorrhages known as ARIA. Likewise, aducanumab is inappropriate for anyone who has had more than four microhemorrhages, or any larger brain bleed.
Meanwhile, in Washington, D.C., the Centers for Medicare and Medicaid Services is deliberating whether to cover Aduhelm, or go for a coverage with evidence development program. When Medicare rejects coverage of an FDA-approved drug, state Medicaid programs pick up the cost; alas, resistance seems to be forming among some state Medicaid directors. Today, Stat reported that Oregon is preparing a request to be released from this requirement. Factors such as age, sex, disease stage, or use of blood thinners did not affect ARIA-E incidence in these trials. In contrast, the presence of microhemorrhages at study baseline nearly doubled a person’s risk. APOE genotype likewise had a large effect, with ARIA-E incidence being 20 percent in noncarriers, 36 percent in heterozygotes, and 66 percent in homozygotes.
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As in the trial population, patients could be taking cholinesterase inhibitors or memantine. With all the attention on aducanumab and donanemab these days (see previous stories in this series), lecanemab has been flying under the radar. Yet this often overlooked anti-amyloid antibody from Eisai/Biogen potently clears amyloid while producing less brain edema than its competitors. Lannfelt led the BioArctic Neuroscience team that developed this antibody.
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Centers for Medicare and Medicaid Services (CMS) issued a national coverage decision restricting Aduhelm coverage to clinical trials (see Apr 2022 news; Feb 2022 news; Jan 2022 news and commentary). Soon after, Biogen withdrew its marketing application before the EMA (press release) and announced cutbacks in its Aduhelm marketing efforts but a continuation of some ongoing Aduhelm clinical studies (May 2022 news). On May 20, the company terminated the ICARE-AD real-world use study. Also at AAIC, an observational study to obtain real-world effectiveness and safety measures was introduced. Called ICARE-AD, the study will follow 6,000 people on Aduhelm for up to five years, aiming for at least 1,000 African-American and Latino participants.
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A subsequent analysis of the CSF biomarkers Aβ40, Aβ42, pTau-181, and total tau found robust concordance with amyloid PET status, particularly when biomarker ratios were used (Nisenbaum et al., 2023). Individual fluid needs vary based on age, sex, activity level, and medical history. For optimal hydration, experts generally recommend drinking approximately 9 cups of water per day for women and 13 cups of water per day for men. When adding beverages to your meal plan, consider their calorie count. Aim to reduce or eliminate consumption of sugar-sweetened beverages, and opt for water when possible.
You can also save your favorite recipes and use them to build your own meal plans using our free templates. Dorene Rentz at Brigham and Women’s Hospital, Boston, said that even with these AUR, primary care physicians may have trouble selecting the right patients for aducanumab. “Referral to specialists, including behavioral neurologists, dementia experts, and neuropsychologists, should be required prior to administration of the drug,” she wrote to Alzforum. For a start, the panel recommended that clinicians obtain a detailed medical history, test cognition, and perform a thorough neurological exam as first steps in their evaluation of whether the patient before them might benefit from aducanumab. “You don’t treat a number, you treat an individual,” he said at AAIC.
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- What would be the effect of having up to four immunotherapies available to treat AD?
- On November 6, 2020, an FDA advisory committee voted against approval, citing weaknesses in the efficacy data, and recommended a confirmatory trial (see Nov 2020 news and Nov 2020 news for commentary).
- Targeting tau in the continued presence of amyloid could be an uphill battle, Bateman said.
- When those participants were excluded from the analysis, the results were no longer significant, going from a p value of 0.04 to 0.1, Massie calculated.
- On January 27, 2020, Biogen listed a Phase 3b open-label study for 2,400 previous aducanumab trial participants, who will receive monthly injections of 10 mg/kg for two years.
Alzheimer’s researchers were unsurprised, and said the decision would have little effect, because very few patients were aducanumab price in india taking aducanumab. “I don’t think this drug ever had a future after Medicare and insurers declined to provide coverage,” Ian Grant at Northwestern University in Chicago wrote to Alzforum. James Noble at Columbia University in New York noted that lecanemab simply out-competed aducanumab, with more convincing data showing it was effective and safe.
If lecanemab mostly targets protofibrils, how does it clear fibrillar plaque? Lannfelt believes the antibody shifts the equilibrium in the brain by depleting soluble species. This would cause more Aβ to solubilize off plaques, dissolving these deposits, he suggested.
- Some commentators recommended that futility analyses be applied with more nuance.
- “It suggests that early seeding is a slow process and that it takes a long time to regenerate seeds if they are removed,” he added.
- I hope an aducanumab study using presymptomatic APOE4 subjects will be considered in the future,” Gibbs said (full comment below).
- Called ICARE-AD, the study will follow 6,000 people on Aduhelm for up to five years, aiming for at least 1,000 African-American and Latino participants.
The resulting controversy led to resignations, congressional investigations, and a negative coverage decision by the Centers for Medicare and Medicaid Services (Jun 2021 news; Jan 2022 news; Jan 2023 community news). Three-quarters of all ARIA cases were asymptomatic and detected only on MRI. Of the symptomatic cases, two-thirds were mild, with the most common symptoms being headache, confusion, dizziness, and nausea.
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Swanson updated the CTAD audience on the Phase 3 Clarity trial, which now has 1,795 participants. Demographics are similar to the Phase 2 trial, except the participants are more diverse. Phase 2 was 90 percent Caucasian, whereas Clarity’s population is 17 percent Asian, 13 percent Hispanic, and 3 percent black (Nov 2020 conference news). Christopher van Dyck of Yale University in New Haven, Connecticut, agreed that plasma biomarkers need further validation before they can be used to predict clinical outcomes. Nonetheless he was impressed with the lecanemab data, noting that the cognitive benefit maintained off drug strongly suggests a disease-modifying effect.
This necessitated pauses in dosing, and MRI monitoring until the condition cleared up. Thus, affected participants became aware they were most likely on drug, as did some of their physicians. This may have affected ratings on the CDR-SB and activities of daily living (ADL) scales, which are somewhat subjective to begin with because they are based on information provided by the patient and his or her care partner.