Alzheimer’s blood test gets FDA breakthrough device designation
WEBMar 14, 2024 · by Margarida Maia, PhD March 14, 2024. The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Quanterix ’s experimental blood test measuring p-Tau 217, the protein that builds up as toxic tangles in the brains of people with Alzheimer’s disease. The test, Simoa p-Tau 217, has the potential to help doctors ...
Acumen’s ACU193 Antibody for Early Alzheimer’s on FDA Fast Track
WEBNov 22, 2022 · Ongoing INTERCEPT-AD trial still recruiting at multiple sites in US. An ongoing Phase 1 clinical study (NCT04931459), called INTERCEPT-AD, is currently testing how safe and well-tolerated ACU193 is versus a placebo in up to 62 people, age 55–90, with mild cognitive impairment or mild dementia due to Alzheimer’s.. The trial is also testing the antibody’s pharmacokinetics (its movement ...
How to Support a Friend With Alzheimer’s and Their Family
WEBAug 17, 2020 · The correct response may be to just be there, present in your friend’s mourning and sadness. Respond with a listening ear when your friend needs to vent. You could also find a practical way to get involved to help heal a friend’s heartache. Choose one of the following ideas or come up with a plan that is unique to your friend’s experience ...
ALZ-801 for 2 years seen to sustain cognition in early Alzheimer’s
WEBSep 22, 2023 · These are the top-line findings of an ongoing Phase 2 clinical trial (NCT04693520), whose two-year data also showed that Alzheon’s experimental therapy preserved the hippocampus, a brain structure important for memory that is damaged first in Alzheimer’s.. Importantly, ALZ-801’s safety profile over two years continued to show no increased risk of brain swelling and bleeds, which have ...
Biomarker test to diagnose Alzheimer's wins FDA breakthrough...
WEBMay 2, 2024 · The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Elecsys Phospho-Tau 217 (pTau217), a blood-based biomarker test that can help distinguish Alzheimer’s disease from other neurodegenerative disorders. The test, developed by Roche in collaboration with Eli Lilly, is …
Topline results of Phase 3 studies of simufilam for Alzheimer's...
WEBFeb 8, 2024 · Two Phase 3 clinical trials are testing the effectiveness of simufilam, an experimental oral therapy that’s designed to improve cognition in people with Alzheimer’s disease.. Top-line results from the RETHINK-ALZ trial (NCT04994483) are expected by the end of this year, according to simufilam’s developer Cassava Sciences.Results from the second study, REFOCUS-ALZ study (NCT05026177), are ...
FDA approves donanemab, now Kisunla, to treat early Alzheimer's
WEBJul 3, 2024 · The U.S. Food and Drug Administration (FDA) has approved Eli Lilly ‘s antibody therapy donanemab, now Kisunla, for certain adults with Alzheimer’s disease. Specifically, Kisunla is indicated for patients with early symptomatic Alzheimer’s — to include individuals with mild cognitive impairment …
Medicare now will cover costs of amyloid PET scan in Alzheimer's
WEBOct 20, 2023 · An amyloid PET scan typically is more sensitive than other imaging scans, and thus may be a better tool for making a diagnosis. However, such tests are expensive: Without insurance, amyloid PET scans can cost an average of $3,000 per test or more. People on Medicare generally pay 20% of the costs of …
Simufilam aids cognition in 47% of Alzheimer's patients in Phase 2...
WEBMar 14, 2023 · The Phase 2 trial runs for two years, with treatment safety and tolerability being measured over that time. Enrolled patients are randomized to a full two years of simufilam at 100 mg twice daily, or to one open-label year of treatment followed by six months of a placebo tablet (months 12 to 18), before returning to the treatment for a …
Approved Treatments for Alzheimer's Disease
WEBAug 1, 2024 · Namenda (memantine) is an approved medicine for the treatment of moderate to severe Alzheimer’s disease. When nerve cells are damaged, it is believed that some start to release excess glutamate, leading to too much calcium entering cells. Namenda works to block glutamate, which is involved in learning and memory, from accessing NMDA receptors ...