We interrupt this text series to share new news about Alzheimer’s.
Brain Science:
You remember we said several months ago that there was no cure for Alzheimer’s. Well, there has been a lot done over the past few months. This text is about recent development drugs and treatments. To make a long story short it looks like there are three significant drug treatment options that are about to become available. These are not widely known because they are in the process of clinical trials. Clinical trials can sometimes last for years and the process is open to wide interpretation. However, the following three have shown great promise and likely on fast tracts.
Brain Facts:
· The three are: 1. Butanetap 2. Aducanumab/ Lecanemab 3. Alzamend Vaccine.
· Butanetap: Is being developed for Alzheimer’s and Parkinson’s disease. It works by lowering levels of toxic clumps that accumulate in nerve cells of people with these neurodegenerative diseases. Data shows the treatment reduced the accumulation of both amyloid-beta and tau proteins. You may remember in our previous texts we discussed the tau tangles created by the plaque. These tangles are a major cause of dementia. This treatment to this point shows decline in mild-to – moderate Alzheimer’s. Annovis Bio is the company developing this treatment.
· Aducanmab/ Lecanemab: A Japanese company (Eisai) developed drugs that displayed promise as breakthrough treatments. (Aricept/Aduhelm.) Over the last two years, these have become commercial failures for several reasons. The main drawback of the initial drugs was that, while they showed successive improvements in mental function, they did not slow the advancement of Alzheimer’s.
Eisai subsequently partnered with Biogen who was doing research on a product that was showing progress at blunting the progress of Alzheimers. Biogen is a U.S. based company. An October 24 2022 article in Business Week announced a major breakthrough that was made public the month before. The new drug developed, by both Biogen and Eisai, Lecanemab not only improves cognitive function, it also blunts Alzheimer’s progression. The therapy uses statistical information to set up dosages to individual patients. This, as do most of the new Alzheimer’s drugs, works from the premise of amyloid plaques causing dementia and Alzheimer’s. Obviously PET scans would need to show evidence of plaque build up in order to use this therapy to treat the disease.
· ALZNOO2/ Alzamend Neuro: This is a vaccine! It is designed as a new therapy that alters the progression of Alzheimer’s and prevents reverses and slows neurodegeneration and cognitive decline. This drug is a cell based vaccine designed to use a patient's own immune system to target and eliminate amyloid- beta protein- as we know is a toxin that denigrates the brain, disrupting its function and leads to dementia. The vaccine is an infusion process that so far shows significant reduction of plaques after 90 days. It is possible that this drug could be used as we use other vaccines to ward off pneumonia, T.B. and shingles.
· Status of trials:
Butanetap: This drug has, as of August, successfully completed Phase 2a trials. Usually there are 3 phases to approve a drug through the FDA (Food and Drug Administration). A wild guess would be a year away for final approval. The FDA can introduce several new studies if they feel the need.
Lecanemab: This drug is hot. The National Institute on Aging sent out an official government clinical report on October 3, 2022. It talked about the successful completion of phase 1& 2 studies and published preliminary results on phase three clinicals. This study targeted people who were thought to be particularly susceptible to Alzheimer’s. So far these studies have been especially promising. On November 29 the company will present results at the National Alzheimer’s Disease Conference. Many see this as the beginning of a new era of Alzheimer’s treatment. The accelerated approval of Abucanumab backfired. But it looks like the Lecanemab approval for commercialization will be somewhere around the middle of 2023!
ALZNOO2: This vaccine is in early phases of FDA approval. Phase one is not complete but preliminary (mouse models) support strong indication that immunization will be effective and long lasting. Phase one trials have begun on humans. Positive data to this point have caused planning of phase two, with implementation of phase three months after phase one. Unless there is some reason to hurry up the process the vaccine will not be available for another couple of years.
* There is another older drug “Ganterumab” that had failed 2014 phase 3 studies. Roche, the manufacture, has resumed clinicals. Trials will be on-going through 2013.
So What:
1. Above all remember these drugs are seeking governmental approval. That process, as is much of government, is fraught with political and monetary interference.
2. Your Dr. probably doesn’t know of the latest. According to a 2020 article in The Journal of Prevention of Alzheimer’s Disease, primary caregivers feel ill-equipped even to make a diagnosis of limited cognitive impairment. A special report this year by the Alzheimer’s Association found that about 35% of primary care physicians hesitate to diagnose MCI, while 51%hesitate to diagnose MCI because it leads to Alzheimer’s. As we have learned, if there is hope for recovery, dementia needs to be diagnosed early.
3. Multiple sources recommend contacting the Alzheimer’s Association. Early detection is vital. Should you or anyone in your family experience signs of mild cognitive decline please have a frank and honest conversation with your primary care physician? Try to determine his/her interest in discovery in this area. Either way contact the Alzheimer’s Association. 800-272-3900 24 hour help line. They will talk with you; they have the latest and have referral networks.
4. As of 2011 the Medicare Annual Wellness visit was a part of the Affordable Care Act. That Medicare benefit includes the creation of a personalized prevention plan and detection of possible cognitive impairment! Have you seen one I haven’t?
5. We are on the cusp of tremendously significant life changing therapies for the treatment of dementia and Alzheimer’s. It looks like an exciting road ahead. If you know! (You may want to print this for future reference.)
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