Drugs To Treat Alzheimer’s Disease

Who Is A Candidate For Aducanumab

Based upon the clinical trials in which it was studied, the drug can be potentially considered for use in individuals with early-stage Alzheimers disease. This means individuals who have Alzheimers in its mild cognitive impairment or mild dementia stage. Individuals in this early stage of Alzheimers may be able to function normally, or they may require a little bit of help with complicated activities like paying bills, grocery shopping, preparing meals, or balancing their checkbook. Individuals who need help with dressing, bathing, or other basic activities would be beyond the early stage and the drug would not be indicated for them.

Note that not everyone with mild cognitive impairment or mild dementia has Alzheimers disease. There are other causes of these problems as well. To determine if Alzheimers is present, you need to get either an amyloid PET scan or a lumbar puncture to be sure you have the amyloid plaques of Alzheimers. Currently, a lumbar puncture is generally covered by insurance, but an amyloid PET scan is not.

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.

Complementary And Alternative Medicine

Since medications have had limited benefit in treating Alzheimer’s, many have turned to alternative and complementary treatments. The jury is still out on many of these approaches, and research is ongoing. Some people have reported an improvement in cognition with various supplements, but none have proven successful enough in clinical studies to warrant recommending them for people with Alzheimer’s disease.

Vitamin E supplementation showed the most promise. But according to the National Center for Complementary and Integrative Medicine, there was only evidence from a single study that it might slow functional decline in Alzheimer’s disease.

Studies have shown there may be a protective effect of eating more fish and other foods containing omega-3 fatty acids, specifically docosahexaenoic acid . But giving people supplements of DHA after they have been diagnosed with Alzheimer’s disease has shown no benefit.

Other CAM options that have been studied include ginkgo biloba, which has no conclusive evidence of preventing or slowing Alzheimer’s disease, and curcumin, which doesn’t have enough research yet conducted to support its use.

If you’re interested in trying complementary or alternative treatments, you should discuss them with your healthcare provider, since some have the potential to interact with other medications or may trigger significant side effects.

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But Does The Drug Work

In a prior blog post I reviewed the publicly available data and the daylong FDA hearing on aducanumab. In a nutshell, there were two large clinical trials to assess effectiveness, side effects, safety, and how the drug might be used in clinical practice. One of the studies was positive, meaning that the drug worked to slow down the decline of thinking, memory, and function that is usually impossible to stop in Alzheimers. The other large study was negative. In my view and that of the FDA advisory panel these results mean that we dont know if the drug works or not.

Another factor to consider is that the potential benefit if the drug works as well as it did in the positive study was fairly small. Looking at the two objective measures, in the positive trial, the high dose made a 0.6-point change on the 30-point Mini-Mental State Examination. On the 85-point Alzheimers Disease Assessment ScaleCognitive Subscale-13, the high dose made a 1.4-point change.

Who Will Potentially Benefit And What Needs To Happen Before A Patient Starts Receiving This Drug

Before a patient is recommended for this treatment they will undergo a series of tests to determine if they meet the disease criteria that has the best chance of seeing a positive outcome. I would say that the appropriate people are people with Mild Cognitive Impairment due to Alzheimer’s disease, and people with very mild stage Alzheimer’s disease that are confirmed to have an elevated amyloid burden, so there’s biomarker verification that they have Alzheimers disease and not another form of dementia or cognitive impairment. That can happen through a PET scan, cerebral spinal fluid or, in the near future, through blood biomarkers. It is also important that patients are otherwise healthy and don’t have medical conditions or are on medications that increase their risk of developing and being harmed by amyloid related imaging abnormalities . Patient selection needs to be extremely thoughtful and careful.

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How Is Alzheimer’s Disease Treated

Alzheimers disease is complex, and it is therefore unlikely that any one drug or other intervention will ever successfully treat it in all people living with the disease. Still, in recent years, scientists have made tremendous progress in better understanding Alzheimers and in developing and testing new treatments, including several medications that are in late-stage clinical trials.

Several prescription drugs are already approved by the U.S. Food and Drug Administration to help manage symptoms in people with Alzheimers disease. And, on June 7, 2021, FDA provided accelerated approval for the newest medication, aducanumab, which helps to reduce amyloid deposits in the brain and may help slow the progression of Alzheimers, although it has not yet been shown to affect clinical symptoms or outcomes, such as progression of cognitive decline or dementia.

Most medicines work best for people in the early or middle stages of Alzheimers. However, it is important to understand that none of the medications available at this time will cure Alzheimers.

What Potential New Treatments Are Being Researched

Alzheimers disease research has developed to a point where scientists can look beyond treating symptoms to think about addressing underlying disease processes. In ongoing clinical trials, scientists are developing and testing several possible interventions, including immunization therapy, drug therapies, cognitive training, physical activity, and treatments used for cardiovascular disease and diabetes.

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Prevention Of Alzheimer Disease

There are no proven modalities for preventing AD. Evidence, largely epidemiologic, suggests that healthy lifestyles can reduce the risk of AD. Physical activity, exercise, and cardiorespiratory fitness may be protective.

In a 44-year longitudinal population study of Swedish women, researchers found that a high cardiovascular fitness in midlife was associated with a decreased risk of subsequent dementia. Data show women with high fitness levels had an 88% lower risk of developing dementia compared with women who were moderately fit in midlife. Additionally, when the highly fit women did develop dementia, they developed the disease an average of 11 years later than women who were moderately fit.

A French study of 8,085 nondemented participants aged 65 years and older found that frequent consumption of fruits and vegetables, fish, and omega-3 rich oils may decrease the risk of dementia and AD, especially in APOE E4 noncarriers.

Although no definitive dietary recommendations can be made, in general, nutritional patterns that appear beneficial for AD prevention fit the Mediterranean diet. Following this type of diet, along with recommendations for physical activity, has the added benefit of lowering the risk of cardiovascular and metabolic disorders.

References

Medicines To Be Used With Caution In People With Alzheimer’s Disease

There are some medicines, such as sleep aids, anti-anxiety drugs, anticonvulsants, and antipsychotics, that a person with Alzheimers disease should take only:

• After the doctor has explained all the risks and side effects of the medicine
• After other, safer non-medication options have not helped treat the problem

You will need to watch closely for side effects from these medications.

Sleep aids are used to help people get to sleep and stay asleep. People with Alzheimers disease should NOT use these drugs regularly because they make the person more confused and more likely to fall. There are lifestyle changes people can make to improve their sleep.

Anti-anxiety drugs are used to treat agitation. These drugs can cause sleepiness, dizziness, falls, and confusion. For this reason, doctors recommend they should only be used for short periods of time.

Anticonvulsants are drugs sometimes used to treat severe aggression. Side effects may cause sleepiness, dizziness, mood swings, and confusion.

Antipsychotics are drugs used to treat paranoia, hallucinations, agitation, and aggression. Side effects of using these drugs can be serious, including increased risk of death in some older people with dementia. They should only be given to people with Alzheimers disease when the doctor agrees that the symptoms are severe.

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Discuss With Your Doctor

Should you or a loved one take aducanumab? You should discuss this decision with your doctor. Because we dont know if aducanumab works or not, deciding to take it is similar to deciding to participate in a clinical trial. As mentioned above, the known side effects are that 30% of people experienced reversible brain swelling and more than 10% had tiny brain bleeds. Although it does clear amyloid plaques from the brain, we dont know if it will slow down the dementia or not.

How Is Alzheimers Disease Diagnosed

These tests are used to diagnose Alzheimers disease or to rule out other medical conditions that cause symptoms similar to Alzheimers disease:

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How Long Should Alzheimer’s Drugs Be Taken For

These drugs are usually prescribed for a trial period of 3 to 4 months to see if they show signs of helping.

There is no clear view as to how long they should be taken. If the condition progresses in spite of treatment, there may come a point when you and your doctor decide that there is little point in staying on them.

How Do You Take The Drug And Is It Safe

To take the drug, you need an intravenous infusion every four weeks forever. Thirty percent of those who took the drug had a reversible swelling of the brain, and more than 10% had tiny brain bleeds. These side effects need to be watched closely by an expert neurology/radiology team who understand how to monitor for these events and know when to pause or stop the drug.

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What Lifestyle Changes Can Help

Piles of research over the last few decades have shown that lifestyle factors can have a big impact on the development of Alzheimer’s symptoms. “We are looking not only at therapeutic treatments, but also at how modifiable factors, such as a heart-healthy diet, exercise, health equity, and social engagement can reduce risk the risk of Alzheimer’s,” says Edelmayer. The U.S. POINTER Study is currently evaluating whether lifestyle interventions that target Alzheimer’s risk factors can protect cognitive function in older adults who are at risk for cognitive decline. Meanwhile, the following activities are believed to lower risk and delay the symptoms of dementia:

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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Dosage & Side Effects Of Alzheimer’s Medications

Doctors usually start patients at low drug doses and gradually increase the dosage based on how well a patient tolerates the drug. There is some evidence that certain people may benefit from higher doses of the cholinesterase inhibitors. However, the higher the dose, the more likely side effects are to occur.

Patients should be monitored when a drug is started. All of these medicines have possible side effects, including nausea, vomiting, diarrhea, and loss of appetite. Report any unusual symptoms to the prescribing doctor right away. It is important to follow the doctors instructions when taking any medication, including vitamins and herbal supplements. Also, let the doctor know before adding or changing any medications.

Nice Guidance On Drug Treatments

The National Institute for Health and Care Excellence produces guidance on use of drugs in the NHS. NICE reviews the evidence and decides whether treatments represent good enough value for money to be available as part of standard NHS care. Drugs considered by NICE will also have been through the UK or European licensing process for new medicines. This means the medicine has been tested and met strict standards of safety, quality and effectiveness. The licence will be granted for treatment of a particular health condition .

For the cholinesterase inhibitors, the NICE guidance suggests that the cheapest drug should generally be tried first.

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What Causes Alzheimers Disease

Alzheimers disease is caused by the abnormal build-up of proteins in the brain. The build-up of these proteins called amyloid protein and tau protein leads to cell death.

The human brain contains over 100 billion nerve cells as well as other cells. The nerve cells work together to fulfill all the communications needed to perform such functions as thinking, learning, remembering, and planning. Scientists believe that amyloid protein builds up in the 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, starting in one area of the brain then spreading to other areas, results in the symptoms seen in patients with Alzheimers disease.

Reminiscence And Life Story Work

Reminiscence work involves talking about things and events from your past. It usually involves using props such as photos, favourite possessions or music.

Life story work involves a compilation of photos, notes and keepsakes from your childhood to the present day. It can be either a physical book or a digital version.

These approaches are sometimes combined. Evidence shows they can improve mood and wellbeing.

Find out how to live well with dementia and more useful information in the NHS Dementia Guide.

Page last reviewed: 05 July 2021 Next review due: 05 July 2024

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This Approval Was Not Without Controversy Can You Explain What Happened

The studies, referred to as ENGAGE and EMERGE were stopped prematurely do to a late-stage interim analysis that suggested the studies failed based on a futility analysis. After all the data was collected the findings from the studies went in two different directions. One study was convincingly negative, and the other was convincingly positive. Furthermore, limitations were found in the data this treatment needs to be given with care, over a long period of time to people who meet very particular benchmarks, and has potential side effects that need to be monitored closely, such as swelling of the brain. Yet the clinical end sees hope in this drug delaying the disease progression in patients who meet those specific requirements necessary to receive the drug when compared to placebo. Currently, the FDAs approval is provisional and is based on aducanumabs ability to lower amyloid propensity. Clinical efficacy needs to be validated with at least another confirmatory controlled study and Biogen has committed to completing that study. Our lab is one of the locations that expects to collect data for this study.

Medicines To Treat Challenging Behaviour

In the later stages of dementia, a significant number of people will develop what’s known as behavioural and psychological symptoms of dementia .

The symptoms of BPSD can include:

• increased agitation
• delusions and hallucinations

These changes in behaviour can be very distressing for both the person with Alzheimer’s disease and their carer.

If coping strategies do not work, a consultant psychiatrist can prescribe risperidone or haloperidol, antipsychotic medicines, for those showing persistent aggression or extreme distress.

These are the only medicines licensed for people with moderate to severe Alzheimer’s disease where there’s a risk of harm to themselves or others.

Risperidone should be used at the lowest dose and for the shortest time possible as it has serious side effects. Haloperidol should only be used if other treatments have not helped.

Antidepressants may sometimes be given if depression is suspected as an underlying cause of anxiety.

Sometimes other medications may be recommended to treat specific symptoms in BPSD, but these will be prescribed “off-label” .

It’s acceptable for a doctor to do this, but they must provide a reason for using these medications in these circumstances.

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