Topics About 'Alzheimers Disease'.

Nurses who work with Alzheimer patients and their families do not have to be told about the anguish these families go through as they watch a loved one leave them as they are still physically present. And in the early stages of the disease, the patient also watches what is happening. They have needed hope for a long time. So now there is a new drug, Aducanumab. There is a catch, however, a controversy. I will attempt to present both sides of this controversy, giving voice to those who support the drug and those who don’t. The approval and use of Aducanumab feels like a storm; it has happened so fast. It was approved just this June by the Food and Drug Administration. To those of us paying attention, it feels like it has already been a few years. Three members of the Food and Drug Advisory committee that reviewed the findings of the tests for Aducanumab resigned over its approval. Yet the Food and Drug Administration backs its decision, and patient advocacy groups are thrilled at this seeming breakthrough. Many families and loved ones of patients, and patients themselves, see it as making headway. It is the first novel therapy to be approved for Alzheimer’s since 2003. Aducanumab is an enormous aberration for the FDA. Throughout history, medicine men and later legitimate pharmaceutical companies could sell their wares without proving that they actually work. That ended with the debacle of thalidomide in the 1950s and 1960s. Around the world, many women gave birth to babies with severe birth defects because of this drug that was given for nausea. Dr. Frances Kelsey worked at the American Food and Drug Administration at the time. He pretty much single-handedly made sure the drug did not enter the U.S. Marketplace. Soon after that, the U.S. Congress passed a law (1962) that required pharmaceutical companies to prove extensive drug testing before any medicine can be put to market. Aducanumab (to be marketed as Aduhelm) has been approved against the recommendation of the FDA’s own committee. It has been reported several places, perhaps first, and most notably, by Laurie McGinley in the Washington Post, that the Peripheral and Central Nervous System Drugs Advisory Committee was asked to vote on the drug’s effectiveness. There were a few questions about the evidence. There was not one “yes” vote. Ten members voted no and one uncertain. Yet Aduhelm was still approved under the umbrella of what is known as an accelerated approval pathway. It was approved and announced on June 7, 2021.1 The Food and Drug Administration’s Center for Drug Evaluation and Research director is Patricia Cavazzoni, M.D. She was quoted by the publication Salud America! as saying on June 7, “Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones. Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”2 At least one other doctor echoes her position. Dr. Rany Aburashed is Chief of Neurology at Memorial Healthcare in Michigan. Memorial Healthcare is a hospital with an institute for neuroscience. Jacqueline Howard reported that he was quoted from an email: “…. What is really exciting is that Aducanumab is the first new FDA-approved Alzheimer’s treatment in 20 years, and we’re optimistic this will spark a wave of new research and innovation in this space. Patients are excited for that, too, and if aducanumab is the first step toward that bright future, patients are eager to be part of it.”3 Biogen and its Japanese partner Eisai are the pharmaceutical companies that developed Aducanumab. They claim that the drug slows the decline of mental acuity and cognitive health in Alzheimer’s patients. Again, Jacqueline Howard of CNN reports that Biogen’s documents presented to the committee at the FDA stated that the patients that were given high-dose aducanumab showed 22% less clinical decline in their cognitive health than those who were given a placebo. This was after 18 months of medication. Aducanumab, or Aduhelm, targets amyloid beta plaques. Jacqueline Howard of CNN quotes Dr. Aburashed as writing: “This is the first antibody directed treatment for Alzheimer’s disease that targets the main possible cause of the disease, which many feel is related to the deposition and accumulation of a protein called amyloid beta. The antibody binds to aggregates of the amyloid protein and appears to preferentially target the amyloid plaques in the brain as opposed to those in the blood vessels.”4 Still, the tests were not enough to satisfy the committee at the FDA. And their reaction to Aduhelm’s approval is radical. The first to resign from the FDA for this was Dr. Joel Perlmutter. He is a neurologist at Washington University School of Medicine in St. Louis. He was quoted as saying, “Approval of a drug that is not effective has serious potential to impair future research into the treatments that may be effective.” He was followed in his exit by Dr. Aaron S. Kesselheim, professor of medicine at Harvard Medical School. Dr. David Knopman was the third to leave the FDA. He is a clinical neurologist at The Mayo Clinic. According to several publications, including The Washington Post, he wrote in an email to FDA officials “Biomarker justification for approval in the absence of consistent clinical benefit after 18 months of treatment is indefensible.”5 The problem with Aducanumab, or Aduhelm as it will commonly be known, is that patients and families are so desperate for something, anything that just might work. There are two major issues with the drug. It has been known to cause the brain to swell and hemorrhage. The other drawback is that it costs $4,312 per infusion, making an annual cost of $56,000 for a high dose. It is infused intravenously over about an hour every four weeks. Nurses know the implication of that – it acts fast, and there is little time to turn back if there is an adverse reaction. Is there an antidote yet to Aduhelm? Nevertheless, people are anxious to take the drug or see their loved ones take the drug. Kurt Rehwinkel is a spouse to a patient taking Aduhelm. He does not understand people who want Aduhelm kept off of the market. He said in an interview with NPR’s Jon Hamilton, “I wondered, do these people really have loved ones who have a stake in the game? Are they losing a little bit more of their loved one every day to the disease?”6 As nurses, one of our jobs in all of this will be, as always, to listen empathetically to these patients and their families, giving them as much time, space and reprieve as we can. As always, we have to leave our own opinions to the side while offering compassionate care. References/Resources 1,5 Two Members of an FDA Advisory Committee Quit After Approval of Controversial Alzheimer’s Drug 2 FDA’s Decision to Approve New Treatment for Alzheimer’s Disease 3,4 New Alzheimer’s Drug Aducanumab: Cost, Side Effects, Timeline and Other Questions Answered 6 For Those Facing Alzheimer’s, a Controversial Drug Offers Hope FDA Grants Accelerated Approval for Alzheimer’s Drug Aducanumab (Marketed as Aduhelm) Information FDA’s Decision to Approve New Treatment for Alzheimer’s Disease Three FDA Advisers Resign Over Agency’s approval of Alzheimer’s Drug FDA Approves New Drug for Alzheimer’s, But Scientists Divided Over Decision FDA Grants Accelerated Approval for Alzheimer’s Drug

My friend's eyes' filled with tears as she told me the latest on her mom, "She keeps accusing me of stealing her things! Yesterday she said I came into her room and took her socks off while she was asleep." She smiled wanly. "It would be funny if it weren't so terribly sad." I gave her a hug and we finished filling up our coffee mugs at the restaurant's drink station. I listened for the next thirty minutes while she went through they symptoms her mom was going through which included some of the more classic signs of early Alzheimer's: mood swings, misplacing things, unusual wandering at night. For the past year, Jennifer had been caring for her mom, first in separate households, but more recently she moved her mom into the guest room of her own apartment so she could keep an eye on her. Even though Jenn was a very competent and compassionate orthopedic nurse, this was completely different from what she had learned in school. Having her mother accuse her and be angry with her stirred up a deep sadness, one that acknowledged that the mom she had known all her life was slipping away, being gradually replaced by an unfamiliar lady that occupied the same physical space. It was unsettling and made her wonder out loud if she knew anything at all about Alzheimer's. Having our loved ones experience any serious illness can make us question our own professionalism since we often feel that we should be able to cope with any sort of medical crisis. Alzheimer's or any type of dementia can be particularly trying since it usually involves a long term mental and physical decline that presents unique challenges to the caregiver. Jennifer outlined a few of those: caregiver exhaustion, depression and discouragement. As a Parish Nurse, I work with people in an ongoing Caregiver Support Group. I encouraged Jenn to attend and also suggested some books she might read that would help her reframe her experience from the more familiar mastery that exists in being a professional nurse to the more vulnerable role of daughter and caregiver seeking answers and help on a long journey. I shared with her some of the more difficult trials we discussed in group. Second Guessing Decisions Members of the group express frustration with all the various options for care and with the sense that they are never sure of having done the right thing. An example is the decision not to do a tube feeding. They talk about how that is the easy part-it is harder making decisions about changing food texture, how and when to hand feed their loved one, food refusal and how to react when choking becomes more frequent as the disease progresses. Sleep Disturbances Missing one night of sleep occasionally can be disruptive, but OK. But having every night disturbed leads to excessive fatigue, lack of ability to cope with daytime duties, and depression-for caregivers and for their care recipients. Working with medical professionals to find helpful routines, drugs and respite care can be a partial solution, but chronic loss of sleep may be the #1 hazard of family caregiving. Family Disunity Sometimes people just don't agree on what to do. And very often one family member is left to do the lion's share of the work-bills, doctor's appointments, taxi service, advocacy. If other relatives participate, it can often be hard to coordinate and variety is not the spice of life for a person with memory issues. Making Decisions About Treatment For Co-Morbidities When a dementia patient has advanced heart disease, or their diabetes is out of control because they eat too much sugar, or their routine preventative medicine is due, or they need a joint replacement but rehab would be a real bear-these decisions get complicated. Deciding they are a DNR might be a first step, but there are lots of steps on the road between onset of memory loss and the time when the DNR decision goes into effect. Guilt. Guilt. If sleep deprivation is the #1 hazard of family caregiving, then guilt is the #1 feeling associated with it. Because caregiving is often so intense, decisions must be made and life set into a series of priorities. When finances enter the picture, options can be further limited. The caregiver may feel squeezed in a vice grip of life-stuck between spouse, children, grandchildren, work, time for self-renewal and worship, caring for their own physical bodies, and having some fun. Seeking to maintain a spiritual balance, a life-focus, can become the greatest challenge. After a second cup of coffee and some time to vent, Jenn's eyes cleared up, her shoulders seemed to release some of the tension and she leaned back in the booth. "You know what's hilarious? Mom keeps loosing her underwear! I can't find it in her drawers or in the trash can. Where do you suppose she is stashing it?" We both shook our heads in unison and laughed until we cried. Joy Eastridge

And, so he did. In fact, my grandfather skipped two years of school and graduated high school at the age of sixteen. He went straight on to veterinarian medical school and graduated at such a young age that it was not legal for him to practice solo for the first year. Being a veterinarian was just one of the many accomplishments my grandfather achieved. He was also the town major in the town he practiced medicine and resided. Yet, being a town mayor was chicken feed compared to him being in the Minnesota State Senate. My grandfather made a good amount of money, but it can not be credited to doing autopsies in the ally way behind his house, but to the wise financial investments he made over the years. My grandfather was not a wonderful man simply for his brilliance alone; he also had a great heart. He believed in helping out others in need. There are many things I miss about my grandfather, like his jokes, stories, and card playing. I am missing him right now as I sit writing. However, some times I miss him the most when I am sitting in front of him and talking to him; reminding him that I am Chelsea. No matter how brilliant my grandfather was, no matter how much money he made, or how many people he helped; there is no way for him to think or buy his way out of Alzheimer's disease. Alzheimer's disease is defined as, "a devastating illness characterized by progressive memory loss, impaired thinking, neuropsychiatric symptoms (eg, hallucinations, delusions), and inability to perform routine tasks of daily living" (Lehne, 2007, 198). My grandfather's definition is that, "my brain is rotting in my head." However, Alzheimer's disease is a little more complicated than "brain rot". The exact cause of Alzheimer's disease is not known. Symptoms of Alzheimer's disease range from mild to extreme and generally appear in stages. Mild symptoms may include confusion and short term memory loss; disorientation, such as getting lost in familiar surroundings; problems with routine tasks such as inability to perform mathematical problems or comprehend abstract thought; and changes in personality and judgment (which can be a safety concern). Moderate symptoms include, difficulty with activities of daily living, such as feeding and bathing; anxiety, suspiciousness, and agitation; sleep disturbances; wandering, pacing; and difficulty recognizing family and friends. Severe symptoms include inability to perform activates of daily living, such as eating, dressing, and bathing which requires total dependence on a care giver. At this stage, the victim is unable to remember how to walk, toilet, or swallow, and use minimal to no communication (Lehne, 2007, 200). My grandfather is in the mild symptoms stage, but also presents some of the moderate symptoms. When visiting with my grandfather last summer at the lake, I left the room to change into my bathing suit. Upon returning not five minutes later, my grandfather asked me who I was. He will often ask if he is at his house in town or if he is at the lake cabin. Several times he has stated that he is on his way to visit his mother at the nursing home-she has been dead for at least fourteen years. But, what broke my heart the most was when he asked my grandmother "are you my wife?" Some days are better than others. Some days he remembers and other days it is like he is in the past, stuck behind a thick fog. I fear for the time when that fog will roll in forever. My second semester of nursing school I was assigned to a patient whom I spent an hour chasing around the hospital trying to convince him, then pleading with him to return to his room. He had Alzheimer's disease, more advanced than my grandfather's, which scared me because I felt like I was staring into the eyes of the future. Treatment for Alzheimer's disease includes environmental structuring and drug therapy. According to pharmacologist Richard Lehne, this is achieved by using cholinesterase inhibitors, which modestly improve cognition, behavior, and function, and slightly delays disease progression (Lehne, 2007, 200). But until a drug can be created that completely eradicates this disease, people will continue to loose their loved ones, even though their bodies remain. References Lehne, R. A. (2007). Pharmacology for nursing care (6th ed.). St. Louis, Missouri: Saunders Elsevier. Lewis, S. M., Heitkemper, M. M., & Dirksen, S. R. (2004). Medical ~ surgical nursing assessment and management of clincal problems (6th ed.). St. Louis, Missouri: Mosby