A new Alzheimer’s drug has been shown to successfully slow cognitive decline in patients with the early stages of Alzheimer’s disease. The drug, called Lecanemab, was tested in a clinical phase iii trial and is showing positive results, reducing patient cognitive decline, in a clinical setting, by 27% when compared to a placebo after taking 18 month doses of Lecanemab.
This data is based on measurement gathered from outdated cognitive tests (created in the 1980’s) including: CDR-SB, ADAS-Cog14, and ADCOMS, and ADCS MCI-ADL. These tests are not calibrated with the respect of time, we must measure more precisely along the continuum. This is a major breakthrough for Alzheimer’s research, as it is the first drug to show such promising effects, but we should deeply consider advancing measurements of brain function using more complex tools for a complex human brain.
Are we truly focused on stopping disease progression or might there be an alternative motivation to rush a drug past the FDA…again.
Patients who received the drug saw a significant reduction in their rate of cognitive decline, could this be the start of some positive momentum for the Alzheimer’s disease drug development community and associated pharmaceuticals?
The clinical study of 1,795 participants included people that have been diagnosed with early Alzheimer’s disease. Pharmaceutical companies Eisai from Japan plan to submit marketing authorization applications for Japan and Europe by the end of 2022.
Is this another rush to sell a drug like Aduhelm’s Aducanumab (fda approval hastily established) as a money grab to people with Mild Cognitive Impairment? Let’s take a closer look at how they tested the subjects and the terrible side effect of brain bleeding that this drug produces.
Alzheimer’s Drug Stock – Biogen Booms Again
Biogen stock prices have been on the rise in light of this news, as investors are hopeful that this new drug will be a major advancement in experimental Alzheimer’s drug development for the company.
Biogen is a major player in the drug development community, and with a successful new drug on the market, its stock prices are likely to continue to rise. This is good news for investors, but it remains to be seen whether or not this new drug will actually be effective in treating Alzheimer’s disease. Only time will tell.
The side effects of Lecanemab, a Biogen Alzheimer’s Drug, are still being investigated and more research needs to be done to determine its long-term efficacy, but this is a promising start for a new Alzheimer’s treatment.
Exciting news for patients, families, and researchers alike as Lecanemap moves on an accelerated approval pathway! Let’s keep our fingers crossed that this is the beginning of a new era in therapeutic development.
New Alzheimer’s Drug – How much does it cost?
Aducanumab, the other treatment of Alzheimer’s that was recently fast-tracked for approval by the FDA (food and drug administration), is expected to be priced at around $60,000 per year. This high price tag is likely to cause some backlash among patients and their families, as many will be unable to afford such costly treatment.
Is this price tag on similar drugs an indicator of what is to come for the future of a new Alzheimer’s drug? Will people be able to afford Alzheimer’s treatments and avoid this debilitating disease?
Outdated Cognitive Assessments – Part of the Plan?
Large pharmaceutical companies avoid using the latest technology when running these studies, by avoiding an accurate reading of cognition do we truly know if Lecanemab is working? Our brains our more advanced than a five-point check box questionnaire, but having poor outcome measures seems like a calculated time-honored tradition. At least they are not using the MMSE?
While reviewing the literature it is painful to see these drugs be measured / validated with outdated and ineffective pencil/paper tests from 1980, over 40 years ago! The food and drug administration lets this happen. It was the fds’s decision with Aduhelm and we saw how fast the CEO of Biogen was fired after the horrible cases of brain bleeding were on the rise.
The ADAS-Cog14 has “… eleven ADAS-Cog tasks demonstrate severe ceiling effects in MCI.” The CDR-SB, is another check box questionnaire it baffles the mind; with such incredible funding and test design why would they not pursue a more advanced measure of brain function?
CogniFit has invested decades in perfecting an online Cognitive Assessment Battery to test, measure, and graph/report all domains of brain functionality. Will treatments like Lecanemab hold up to multiple outcome measures that accurately measure cognitive ability? Not forever.
Researchers can use the Cognitive Assessment Battery for free with their research projects, please reach out.
Do amyloid-lowering drugs help patients?
The Alzheimer’s hypothesis suggests that amyloid in the brain cause brain cells become damaged and cause neurodegeneration. Aducanumab and its potential rivals remove protein beta amyloid clumps. Clinical trials, however, have yet to demonstrate the therapeutic effects. This is a particular contention in the case of aducanumab, an immunomodulator marketed by its amyloid targeting drugs rival and which was withdrawn from clinical trials at the end of phase 3. Landmark Alzheimer’s drug approvals confuse the scientific community.
Diversity and Inclusion – Ethnic and Racial Accountability
Ethnic and racial minorities must be included in clinical trials for new Alzheimer’s drugs, as they are often underrepresented in these studies. This can lead to medications and treatments being developed that are not effective for minority populations, which can hurt their health.
Including minorities in clinical trials helps to ensure that the voices of all patients are heard and that the results of the trials accurately reflect the diversity of the population. This is essential for developing medications and treatments that are truly effective for all patients.
Diversity and inclusion should be a top priority in all areas of research, including future development. Nonprofit organization collaboration may help advance this initiative if the Alzheimer’s Association and Alzheimer’s Foundation of America can work together, we do it for the Alzheimer’s patients at the end of the day. We owe it to all patients to ensure that their voices are heard and that they have access to the best possible care.
Future Research to Improve Public Health
We must continue to research an accelerated pathway to better understand the causes and effects of dementia to develop better treatments and support systems for those affected by it. Combining data from cognitive testing, brain imaging (such as positron emission tomography), and biomarkers we may find unrevealed variables.
Monoclonal antibodies may reduce cognitive impairment during first therapy but is that the only treatment option? With dedication and commitment, we can improve the quality of life for all those affected by brain abnormalities and dementia.
Aria Brain Bleeding, Still a Problem?
“Within Expectations” is pharmaceutical jargon to mitigate blowback from potentially lethal side effects. It sits at the top of the press release.
Lecanemab is not without its risks, the most common being brain bleeds and temporary swelling from amyloid-related imaging abnormalities (ARIA). In the clinical study, 26 people had a brain bleed while taking Lecanemab and none in the placebo group. This is a serious side effect that may negate clinical benefit and needs to be monitored closely.
We need to see the numbers and hear from the people who experienced this firsthand, brain swelling and bleeding is a very serious side effect. Additionally, more research needs to be done to determine the long-term efficacy of the drug evaluation process.
However, this is a promising start for a new Alzheimer’s drug and treatment, compared to the FDA approved aducanumab, and offers hope to patients and families affected by the disease.
Cognitive Decline after Covid Vaccine
If you have been experiencing brain fog since getting the covid vaccine, you are not alone. Many people have reported feeling foggy and cognitively confused after getting the vaccine. While this is a common side effect, it can be very concerning and frustrating.
If you are feeling foggy after getting the covid vaccine, there are some things that you can do to help improve your symptoms. First, make sure that you are drinking plenty of water and staying hydrated. Second, try to get regular exercise and take breaks throughout the day to move around and stretch. Third, make sure that you are taking care of yourself mentally as well as physically; get enough sleep, eat a balanced diet, and take some time for yourself each day. Recommendations from the National Institute of Health.
Talk to your Doctor
Finally, if your symptoms are severe or persist for more than a few weeks, talk to your doctor about them. They may be able to recommend some additional treatments or strategies that can help improve your symptoms. Remember, you are not alone in this and there is help available.
Aricept and Aduhelm, Learning from the Past
Eisai, the major Japanese Pharmaceutical company that is making these breakthroughs today is also responsible for the first Anti-Cholinesterate inhibitor that has long since been the standardized treatment for Alzheimer’s disease. They are still selling this drug today, Aricept.
Aricept and Aduhelm are old Alzheimers and dementia drugs. They were some of the first drugs to be approved for the treatment of Alzheimer’s and dementia, but they are no longer the best options available as they are not very effective.
Beta Amyloid Plaques – A Symptom or a Cause?
The CEO of Eisai says “Additionally, the Lecanemab Clarity AD study results prove the amyloid hypothesis, in which the abnormal accumulation of AB in the brain is one of the main causes of Alzheimer’s disease, when targeted with protofibril-binding therapy.” Normal people get amyloid in the brain as well, is this the factor that causes the Tau pathology? Must studies show when you get rid of the amyloid the cognitive status does not change and does not stop the progression of dementia.
The Alzheimer’s field has been ripped apart by infighting around this question. Some researchers believe that beta-amyloid plaques are a symptom of the disease, while others believe that they are actually a cause. This is a critical question that needs to be answered in order to develop effective treatments for Alzheimer’s disease.
There is still much disagreement within the Alzheimer’s research community about this issue, but more research is needed in order to determine the role of beta-amyloid plaques in the development of Alzheimer’s. Hopefully, this new drug will help to shed some light on this question. It seems that since the exposure of fabricated evidence supporting the “Amyloid hypothesis,” researchers have pulled away in search of a more sensible direction.
The billions of dollars spent and years lost exploring this avenue is a good indicator of the status of the Alzheimer’s research community and the reality of the pain to discover a cure without first identifying a cause.
Cognitive Function and Human Services
There is still much work to be done in understanding and treating cognitive and functional decline in people. While there have been some major advances in drugs and treatments for Alzheimer’s disease, there is still much to be learned about how to best care for those who are experiencing a cognitive and functional decline.
There are many different causes of cognitive and functional decline, and it can be difficult to diagnose and treat. There are many support systems available for those who are struggling with cognitive problems and might be developing dementia, however, and with the right support, many people are able to live productive lives despite these challenges. That why we suggest personalized brain training and brain games.
There is clear evidence that early detection is still our best tool to start treatment options early for memory loss and mild dementia. Regardless of the drug’s ability now, more research is required for the new Alzheimer’s drug to analyze longitudinal data on the new treatment.
Alzheimer’s researchers from Eli Lilly, Biogen, and other pharmaceutical companies work around the clock to deploy clinical improvements, strive for surrogate endpoint and eventually deliver the best Alzheimer’s treatments possible, with CogniFit the outcomes should be much more reliable.