Drugs In The Clinical
Some Alzheimers drugs under investigation include:
- JNJ-54861911 This drug blocks one of the enzymes that makes beta-amyloid. It is in phase 3 trials to see if it slows cognitive decline in people who have elevated levels of beta-amyloid in the brain but do not have Alzheimers symptoms. Results are expected in 2024.
- AADvac1 This is a vaccine that prompts the bodys immune system to go on the offense against an abnormal form of tau protein. A two-year phase 2 trial was completed and demonstrated safety and an immunogenic response against the abnormal tau protein in Alzheimers. Larger studies are needed to demonstrate clinical benefit.
Personal Stories About Taking Medicines For Alzheimer’s Disease
These stories are based on information gathered from health professionals and consumers. They may be helpful as you make important health decisions.
As long as I’m doing all right, I would like to stay off of medicines. Some days it’s really hard, because I get confused and even frightened. But I don’t tolerate medicines that upset my stomach very well, and I’d like to stay feeling as well as I can until my disease progresses. My wife knows to put me on medicines if I become violent or if my behaviors become burdensome to her.
Jed, age 62
I was just diagnosed as being in the early stages of Alzheimer’s disease. I’d like to remain as mentally clear as I possibly can for as long as I can. I’m going to try taking a cholinesterase inhibitor called Aricept, because it may help delay the this condition for a few more months. Even though that’s not a long time, every day is precious to me.
My wife, Sally, left instructions that she would like to be put on medicines if her personality changes and memory loss become a burden for me. Her memory loss and thinking problems have become severe, so her doctor has prescribed a new type of medicine called memantine that might reduce these symptoms. Even though no medicine will prevent the disease from progressing, I want to keep my Sally with me for as long as I can.
Joel, age 81
Harrietta, age 73
The Devastation Of Alzheimers Disease
With all this said, we are extremely aware of the gradual and cumulative devastation that Alzheimers disease causes, as patients lose their memory and cognitive functioning over time. In late-stage disease, people can no longer hold a conversation or respond to their environment. On average, a person with Alzheimers disease lives four to eight years after diagnosis, but some patients can live up to 20 years with the disease.
The need for treatments is urgent: right now, more than 6 million Americans are living with Alzheimers disease and this number is expected to grow as the population ages. Alzheimer’s is the sixth leading cause of death in the United States.
Although the Aduhelm data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients. As a result of FDAs approval of Aduhelm, patients with Alzheimers disease have an important and critical new treatment to help combat this disease.
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What These Results Mean For Alzheimers Patients
Eisai continued to complete its phase 3 trial, in a much simpler format this time, with the confidence gained from the detailed phase 2 study that the results would likely show that lecanemab improved patients cognitive function.
In a way, the circumstances surrounding aducanumabs failure relieved some of the pressure for Eisai and lecanemab, as the Alzheimers community now set lower expectations for what to expect from an anti-amyloid drug. Complicating the study, COVID-19 created challenges for the participants, who had to visit clinics or hospitals to receive the drug as an IV infusion over about an hour twice a month. We set up home infusions, remote safety assessments, and remote cognitive assessments, says Irizarry. We tried a whole lot of things to make it easier for people to participate.
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Fortunately, the unmet need for a treatment for Alzheimers ensured that less than 20% of volunteers dropped out of the trial previous studies of drug candidates often saw 20% to 25% of participants leave the study.
In September 2022, Eisais long game paid off, when the company announced that lecanemab was the first anti-amyloid drug to help patients slow their cognitive decline in a phase 3 study. The phase 2 results ended up being quite predictive of the phase 3 results, and we expected that, says Irizarry.
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How Does Alzheimer’s Medication Work
Current treatment options for Alzheimers disease focus on reducing the severity of its symptoms and helping a person with the condition live a functioning life.
There are two major classes of drugs used to slow cognitive decline in people with Alzheimers cholinesterase inhibitors and NMDA receptor antagonists.
There are also drugs used to treat the symptoms of Alzheimer’s disease such as depression and anxiety.
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What Matters Most To You
Your personal feelings are just as important as the medical facts. Think about what matters most to you in this decision, and show how you feel about the following statements.
Reasons to take medicines to treat Alzheimer’s disease
Reasons not to take medicines
I want to keep doing my daily activities as long as I can, even if it means taking medicines.
I want to keep doing my daily activities without relying on medicines.
Fdas Accelerated Approval Program
Aducanumab was approved through the FDAs Accelerated Approval Program, which provides a path for earlier approval of drugs that treat certain serious conditions. This helps people living with the disease gain earlier access to the treatment. The approval of aducanumab was based on the ability of the drug to reduce amyloid in the brain. When using the accelerated approval pathway, drug companies are required to conduct additional studies to determine whether there is in fact clinical benefit after the drug is approved. If the follow-up trial fails to verify clinical benefit, the FDA may withdraw approval of the drug. Results of the phase 4 clinical trial for aducanumab are expected to be available by early 2030.
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Study Design And Data Source
A retrospective cohort study using medical and pharmacy claims was performed in the IBM MarketScan® Commercial Claims and Encounters and Medicare Supplemental databases . The IBM MarketScan® Commercial Claims and Encounters and Medicare Supplemental databases are composed of de-identified patient-level health data regarding the annual medical utilization and expenditures for inpatient, outpatient, and prescription claims for over 90 million employees, their spouses, and their dependents who are covered under employer-sponsored private health insurance or Medicare supplemental insurance in the United States.
What Is Dementia What Is Alzheimer Disease
Alzheimer disease is the most common cause of dementia. Dementia is defined as a condition that affects memory and thinking. When it is more severe, dementia interferes with a person’s daily life. However, it takes a long time for a person with dementia to become impaired. Modern research suggests that dementia takes years to develop. Some estimates suggest that the loss of brain function happens over the course of 12 decades. A person with dementia starts out with typical thinking abilities, and very gradually develops problems with memory. Misplacing keys, forgetting appointments, and mixing up details are common. It is easy to see how a person with mild dementia could overlook these concerns and attribute them to just getting older.
It is at the point when the problem significantly affects the person’s daily life that the term dementia is used. There are many different causes of dementia. Of these, AD is the most common. Because of this, people often use the terms dementia and AD interchangeably. About 5.5 million Americans have AD. It is estimated that more than 360,000 new cases occur each year. This number will probably increase as the population ages, because aging itself is a major risk factor for the development of AD. AD is the sixth leading cause of death for adults. It kills more than 100,000 Americans each year.2
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Is It Safe To Take Alzheimers Medications During Pregnancy
Donepezil should not be used during pregnancy unless the benefit outweighs the risk to the fetus. Memantine use may be acceptable during pregnancy. There are no data associated with aducanumab use during pregnancy and its outcome on the fetus, so always consult your doctor before taking any medicine.
What Causes Alzheimers Disease
An abnormal build-up of proteins in your brain causes Alzheimers disease. The build-up of these proteins amyloid protein and tau protein causes brain cells to die.
The human brain contains over 100 billion nerve cells and other cells. The nerve cells work together to fulfill all the communications needed to perform functions such as thinking, learning, remembering and planning.
Scientists believe that amyloid protein builds up in your brain cells, forming larger masses called plaques. Twisted fibers of another protein called tau form into tangles. These plaques and tangles block the communication between nerve cells, which prevents them from carrying out their processes.
The slow and ongoing death of the nerve cells results in the symptoms of Alzheimers disease. Nerve cell death starts in one area of your brain and then spreads to other areas.
Despite ongoing research, scientists still dont know what exactly causes these proteins to build up. So far, they believe that a genetic mutation may cause early-onset Alzheimers. They think that late-onset Alzheimers happens due to a complex series of brain changes that may occur over decades. A combination of genetic, environmental and lifestyle factors likely contribute to the cause.
Is Alzheimers hereditary?
Researchers dont know why some people get Alzheimers disease and others dont. But theyve identified several factors that increase your risk for Alzheimers, including genetic factors.
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Fighting Depression And Anxiety
Other drugs including antidepressants, anticonvulsants, antipsychotics, anti-anxiety drugs, and sleep aids are sometimes used to treat behavioral problems associated with Alzheimers disease.
When counseling, support groups, or other nondrug methods dont help with depression or anxiety, doctors may prescribe one of the following drugs:
Because of potentially dangerous side effects, doctors prescribe other drugs with extreme caution.
Insomnia can be a problem for some people with Alzheimers, but sleep aids such as zolpidem can cause confusion and lead to falls.
Antipsychotics like risperidone can increase the risk of death in some older people with dementia, so doctors prescribe them only as a last resort to alleviate severe hallucinations, paranoia, agitation, and aggression.
Benzodiazepines, such as diazepam , should also be generally avoided in patients with Alzheimers disease. There is also some research that shows a correlation between benzodiazepine use and an increased risk of being diagnosed with Alzheimers.
Is It Safe To Drink Alcohol While Taking Alzheimers Medications
It is best to avoid alcohol if you have Alzheimers disease. Excessive alcohol consumption over a long period can lead to brain damage and increase the risk of dementia. Moreover, people with Alzheimers disease may not remember how many drinks they had in a sitting. Alcohol can also interact with certain medications for Alzheimers disease. Combining donepezil and alcohol can prevent the drug from working effectively, thereby increasing the side effects.
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What The Data Show
The late-stage development program for Aduhelm consisted of two phase 3 clinical trials. One study met the primary endpoint, showing reduction in clinical decline. The second trial did not meet the primary endpoint. In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion. It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.
We know that the Peripheral and Central Nervous System Drugs Advisory Committee, which convened in November 2020 to review the clinical trial data and discuss the evidence supporting the Aduhelm application, did not agree that it was reasonable to consider the clinical benefit of the one successful trial as the primary evidence supporting approval. The option of Accelerated Approval was not discussed by the Advisory Committee. As mentioned above, treatment with Aduhelm was clearly shown in all trials to substantially reduce amyloid beta plaques. This reduction in plaques is reasonably likely to result in clinical benefit. After the Advisory Committee provided its feedback, our review and deliberations continued, and we decided that the evidence presented in the Aduhelm application met the standard for Accelerated Approval. We thank the Advisory Committee for its independent review of the data and valuable advice.
With Fda Accelerated Approval Of Alzheimers Drug Lecanemab Likely January 6th Discussion Turns To Price And Reimbursement
FILE – This file photo shows a closeup of a human brain affected by Alzheimer’s Disease. Lecanemab, … a beta amyloid-directed monoclonal antibody, has demonstrated modest efficacy – slowing cognitive decline – in a Phase 3 study.
AP2003
According to the Institute for Clinical and Economic Review , the beta amyloid-directed monoclonal antibody, lecanemab, must be priced lowerthan $20,600 a year to be cost-effective. Specifically, ICERs calculations suggest that the Alzheimers Disease drugs demonstrated benefits in a Phase 3 trial – a modest but statistically significant slowing of cognitive decline – are valued at between $8,500 and $20,600 per year.
Lecanemabs PDUFA* date for its potential accelerated approval is January 6th. The product could launch after its approval by the Food and Drug Administration . And so now the discussion turns to what price it will be launched at, as well as whether it will eventually be reimbursed by Medicare, the predominant payer for a product such as lecanemab.
We dont know yet what lecanemabs price will be. However, in June 2022, Eisai, one of the two sponsors of lecanemab, concluding that lecanemab would be cost-effective at between $10,000 and $35,000 per year.
However, its important to note that whatever price Eisai and Biogen decide on, it may not matter in the short term, at least as far as Medicares reimbursement is concerned.
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What Are The Most Common Medications
Some of the commonly used medications for Alzheimers disease include:
How Was The Study Done
The authors used information from a database that was started in Sweden in 2007. The database is called the Swedish Dementia Registry . Between 2007 and 2017, 78,346 people who were diagnosed with dementia were entered into the SveDem database. There were several causes of dementia that were represented in the group. The 2 most common were Alzheimer dementia and mixed Alzheimer dementia . These types were followed by unspecified dementia , vascular dementia , Lewy body dementia , frontotemporal dementia , Parkinson disease with dementia , and other . For their study, Xu and colleagues included all patients from the database who had either Alzheimer dementia or mixed Alzheimer dementia, for a total of 39,196 people. The researchers also excluded people for whom data critical to the study were not listed. These data included age, sex, and a clear diagnosis.
The researchers identified 11,652 people from the database who were taking a ChEI. They then compared them to 5,826 people who had been diagnosed with mild to moderate AD, but who were not taking a ChEI. Sixty-two percent of the group were women. On average, their age was between 75 and 87 years. Among ChEI users, 62% were taking donepezil, 21% were taking galantamine, and 17% were taking rivastigmine. The researchers found that the most common conditions group members had in addition to AD or dementia were high blood pressure , stroke , diabetes , irregular heart rate , and cancer .
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Popular Drugs Linked To Dementia And Memory Loss
By Ethan Boldt
Any time you take a medication, weighing the risks and benefits of the drug is a must. And now we must ask ourselves, Is this one of the drugs linked to dementia and memory loss? Emerging research is finding disturbing connections between anticholinergic drugs and negative brain effects. This drug class includes popular medications used for allergies, seasickness and sleep, including diphenhydramine, dimenhydrinate and others.
And yes, youd think some of the most popular allergy and insomnia drugs on the market would be safe, but one study outlines some frightening health risks. The JAMA Neurology study is unique because Indiana University School of Medicine researchers actually used brain imaging to detect how anticholinergic drugs impact the brain. Using MRI and PET scan imaging, researchers showed how people taking anticholinergic drugs experienced lower brain metabolism and higher brain atrophy.
This isnt the first time researchers found a connection between anticholinergic drugs and cognitive decline. In 2015, University of Washington scientists also found the chronic use of certain anticholinergic sleep aids and hay fever meds in the increased a persons risk of dementia. The study only found the association for people taking these drugs for 3 or more years.