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Clinical Trial Myths vs Facts

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Clinical trials tend to have a cloud of negative talk hovering over them. Participating in something that involves your health can be daunting and scary, and unfortunately, this fear has led to some misconceptions about participating in clinical research trials.

Here are some of the common Myths/Facts surrounding clinical trial participation:

Myth: Clinical trials are dangerous.

Fact: There will always be risks associated with medical research when testing new and unproven treatment options. Uncomfortable side effects may occur. However, clinical trials are federally regulated and there are ethical and legal codes that apply to each study. If you are considering participating it is important to discuss risks and benefits with your doctor. All studies are voluntary and participants can withdraw at any time.

Myth: The quality of care is not as good as the care I currently receive with my doctor.

Fact: Clinical trial participants receive a high level of care and are highly monitored for any side effects that may occur. All participants are able to discuss any areas of concern with the study staff, and the participants primary care provider may also be involved. For some living with Alzheimer’s disease, research shows that they do better while participating in clinical trials.

Myth: Clinical trials will not accept me as a participant because I have another disease or condition.

Fact: Other chronic medical conditions may be present along with Alzheimer’s disease, and some clinical trials may be designed to accommodate this. Each study has its own inclusion and exclusion criteria. When discussing participation during the informed consent process, be sure to let the study team know of any medical conditions that are present. 

Myth: If clinical trials are so important, my doctor will encourage me to participate.

Fact: There are hundreds of clinical research studies being done across the country. Your physician may not be aware of which of these studies are in your area, or which studies you may be eligible to participate in. Be sure to discuss any clinical trial opportunities you find with your doctor.

Myth: Clinical trials are not confidential.

Fact: When you enroll in a study there are pieces of personal information that will need to be collected and shared with the study team and study sponsor. This generally includes date of birth, medical history, any results collected throughout the study etc. This information is kept confidential to an extent which means that it is given a blinded number to protect your identity throughout the study. Although your information is shared with the study sponsor and FDA, it is our highest priority to maintain our participants information and dignity.

Myth: The study site/team knows who is actually getting the drug.

Fact: In randomized clinical trials there is a group receiving a placebo and a group receiving the study drug. Neither participants nor study team is aware of which participant is receiving a placebo or not. This information is not released until the closing of each study. Make sure that you are okay with the potential chance of getting a placebo when considering participation in a clinical trial.

Myth: The drugs being tested in clinical trials haven’t been tested on humans yet, I’d just be a “guinea pig.”

Fact: The drugs tested in clinical trials have been researched and evaluated multiple times before they can be used in a clinical trial.

Myth: Clinical Trials don’t work.

Fact: Clinical trials are needed to find safe and effective new treatments for various medical conditions. Some trials show more success than others, but not all trials are failures.

Here are two videos that may be helpful when considering a clinical trial. Clinical Trials.gov also has a helpful page with Questions To Ask, and the Alzheimer’s Association has a page discussing How Clinical Trials Work.

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Sources: 
10 Misconceptions About Clinical Trials Debunked [Internet]. Rox Medical. 2018 [cited 2019Apr29]. Available from: https://www.roxmedical.com/news/10-clinical-trial-misconceptions/
Clinical Trials: Myths vs. Facts [Internet]. Alzheimer’s Disease and Dementia. [cited 2019Apr29]. Available from: https://www.alz.org/alzheimers-dementia/research_progress/clinical-trials/myths-vs-facts
How Clinical Trials Work [Internet]. Alzheimer’s Disease and Dementia. [cited 2019Apr29]. Available from: https://www.alz.org/alzheimers-dementia/research_progress/clinical-trials/how-trials-work
Learn About Clinical Studies [Internet]. ClinicalTrials.gov. [cited 2019Apr29]. Available from: https://clinicaltrials.gov/ct2/about-studies/learn

 

 

Tips and Resources For Caregivers

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According to the Alzheimer’s Association, 16.1 million Americans provide unpaid care for people with Alzheimer’s disease or other dementias, resulting in an estimated 18.4 billion hours of care.

While being a caregiver is gratifying, it is also associated with physical, psychological, and financial burdens. It is common for caregivers to report a decline in their own health while caring for another, and it compromises their ability to be a reliable and effective caregiver. Many caregivers report having less time for family and friends, experiencing increased emotional stress, and decreased self-care. Self-care includes maintaining healthy dietary, exercise, mental health, and sleep habits. [1]

It is important that caregivers receive support and develop a system that allows them to tend to their own mental and physical health. Caregivers need to take breaks, monitor their own health, practice self-care, and seek out a support group or similar resource when needed. The stress associated with being a caregiver can result in depression and anxiety.

The Caregiver Action Network (CAN) states:

  • Family caregivers who provide care 36 hours or more weekly are more likely than non-caregivers to experience symptoms of depression and anxiety.
  • Spouses providing care experience symptoms of depression or anxiety at a rate of six times higher than non-caregivers.
  • Family caregivers caring for a parent experience symptoms of depression or anxiety at a rate that is twice as high as non-caregivers.

 The CAN provides resources to monitor caregiver depression including a caregiver depression test, found here.

There are many online resources that give caregivers access to informational video resources, discussion forums, helpful checklists, safety tips and more. Every person’s experience with Alzheimer’s disease is unique and different, but having basic resources available to turn to can provide comfort and help reduce stress.

I’d like to share two main resources. The first being The Caregiver Action Network (CAN), a non-profit organization mentioned earlier. Their site offers a caregiver toolbox loaded with helpful tips, as well as, access to an online care community, video and story library, ways to cope with Alzheimer’s disease etc.

 CAN offers information for any caregiver, not just those caring for someone with Alzheimer’s disease. The website primarily focuses on Alzheimer’s, Huntington’s, Parkinson’s, and COPD. Their website can be accessed here. 

The second great resource I’d like to mention is the Alzheimer’s Association. Their website provides information and educational material for those living with Alzheimer’s, caregivers, and volunteers. The Alzheimer’s Association offers many support groups for those with Alzheimer’s as well as their caregivers. To find support groups in your area click this link. 

Additional support can be found via the National Institute on Aging and the Family Caregiver Council. 

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Sources: 
[1] Collins, Lauren & Swartz, Kristine. (2011). Caregiver Care. American family physician. 83. 1309-17.
[2] Depression Test [Internet]. Screening 2 Supports. [cited 2019Apr19]. Available from: https://screening.mentalhealthamerica.net/screening-tools/depression?ref=CAN
[3] Home [Internet]. Caregiver Action Network. [cited 2019Apr19]. Available from: https://caregiveraction.org/

IDEAS Study Results

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The Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) Study was a 12 month, observational, open-label, longitudinal study done from February 2016 to December 2017. This study was done to assess the impact of amyloid PET scans on patient outcomes. An amyloid PET scan of the brain can identify underlying Alzheimer’s disease even in people with no cognitive complaints. The study was made up of 18,848 participants who were referred by qualified dementia specialists and met inclusion criteria specific to this study, including mild cognitive impairment or mild dementia.

The study hypothesized that, in diagnostically uncertain cases, knowledge of amyloid status as determined by a positive amyloid PET will lead to significant changes in patient management, and that this will translate into improved long-term outcomes.

What did the study find?

The press release announcing the IDEAS Study publication states that the study revealed that providing clinicians with the results of PET scans that identify amyloid plaques in the brain changed medical management – including the use of medications and counseling – in nearly two-thirds of cases. The study also showed that amyloid PET scans altered the diagnosis of the cause of cognitive impairment in more than one in three study participants.

The Alzheimer’s Association chief science officer and co-author of the study, Dr. Maria C. Carrillo, PhD, stated that these study results, “Present highly credible, large-scale evidence that amyloid PET imaging can be a powerful tool to improve the accuracy of Alzheimer’s diagnosis and lead to better medical management, especially in difficult-to-diagnose cases.”

The Center for Medicare & Medicaid Services’ (CMS) wanted to find out if it would be worthwhile to reimburse for amyloid PET scans. These scans are very expensive and not covered by Medicare or health insurance plans, making them inaccessible to those who might benefit from them. For the cost to be covered by CMS, it must be demonstrated that the patient outcomes are affected by the result of a scan. It is unclear if the results from this study will help persuade the CMS on this matter.

A second phase of the IDEAS Study recently ended in February 2019, however, it may take up to a year to be published. Conducting another IDEAS Study in the future with a more diverse study population and to address other gaps in the previous study is also being discussed.

For more information about the IDEAS Study visit the following links:

If you are interested in other biomedical research, visit JAMA’s website.

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Sources:
Results from IDEAS Study Published [Internet]. ALZFORUM. [cited 2019Apr16]. Available from: https://www.alzforum.org/news/research-news/results-ideas-study-published
DanThemes. [Internet]. The IDEAS Study – Brain amyloid imaging in Alzheimer’s disease. [cited 2019Apr16]. Available from: https://www.ideas-study.org/about/educational-resources/the-ideas-study-brain-amyloid-imaging-in-alzheimers-disease/
Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) Study – Full Text View [Internet]. Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) Study – Full Text View – ClinicalTrials.gov. [cited 2019Apr16]. Available from: https://clinicaltrials.gov/ct2/show/NCT02420756?term=IDEAS&cond=Alzheimer Disease&cntry=US&rank=3

Hobbies, Are They Really That Important?

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Many of us are stretched for time and lead busy lifestyles. By the time we reach the end of our day, the idea of sitting in front of the TV seems very appealing.

However, there could be a more proactive and beneficial use of our time! It may seem like we don’t have time for hobbies, but hobbies that are developed or maintained early on in our lives may help us stave off the symptoms of Alzheimer’s disease or other dementias.

Hobbies may protect our brain. An article in Psychology Today states that engaging in a hobby at least one hour per day may protect against Alzheimer’s later in life. Hobbies may also help improve your function as you age. A 2016 study found that those without hobbies or a perceived purpose in life have a significantly higher risk of not only mortality, but also a decline in activities of daily living [6].

Not only can a hobby keep your cognitive abilities strong, it can also have positive effects on your mood. Hobbies are fun and enjoyable. They can provide comfort, reduce the risk of depression, increase socialization, and even improve physical health.  Art  based hobbies provide a chance for self-expression and a chance to process reactions to emotions and ideas. An article exploring the link between painting and dementia states that, “Artistic production itself is a complex cognitive behavior involving at least vision, praxis, memory, and executive functions: this list does not even consider the kind of emotional processing and inspirations that might give birth to such art” [1]. A 2011 study states that art therapy has been reported to improve attention, interest,  joy, self-respect, and quality of life in those with dementia [3]. The National Institute on Aging states that engaging in creative activities can improve creativity, memory, and problem solving skills. Some art related hobbies include drawing, painting, collage, knitting, weaving, coloring, do it yourself (DIY) projects, and woodworking.

If you are reading this and currently don’t practice any hobbies, don’t fret! New hobbies can always be learned and will help stimulate your brain. Starting a new hobby can help you acquire new skills that may serve you later in life. Remember to stay socially active as well. Interacting with others is very important and even provides an opportunity to share your hobbies with others. Here is a list of possible hobbies: playing cards, gardening, swimming, yoga, photography, caring for a pet, or volunteering. The Alzheimer’s Association says that physical activities increase blood and oxygen flow to the brain and improve brain health. Walking is a great physical hobby!

 If you or your loved one is currently diagnosed with Alzheimer’s disease or a form of dementia, hobbies can help increase a sense of purpose in life and overall quality of life throughout the stages of the disease. Alzheimer’s patients without daily hobbies may experience a faster progression of symptoms or  worsening cognitive function. Many hobbies can be even adapted to be more enjoyable for those with dementia as their symptoms worsen. Cooking can serve as a hobby, as well as, encourage socialization and interaction with others. Indulging in your loved ones hobbies can help them better deal with the loss of their cognitive abilities. If you are a caregiver to a loved one with Alzheimer’s, click on this link for some Tips to Help a Person With Dementia Make An Activity Fun. The repetitive aspect that hobbies provide helps those with Alzheimer’s continue to do things that bring them joy. An article in the American Journal on Aging [7] states that, “Hobbies help people to identify and recognize remaining abilities; they communicate information to others, and reflect personality and family background. Hobbies also are cultural activities connecting a person with their background, and to the larger community.”

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Sources: 
[1] Cipriani, G., Cipriani, L., Danti, S., Picchi, L., & Fiorino, M. D. (2019). Links Between Painting and Neurology: The Example of Dementia. American Journal of Alzheimers Disease & Other Dementias®,153331751982629. doi:10.1177/1533317519826293
[2] Duan, Y., Lu, L., Chen, J., Wu, C., Liang, J., Zheng, Y., . . . Tang, C. (2018). Psychosocial interventions for Alzheimer’s disease cognitive symptoms: A Bayesian network meta-analysis. BMC Geriatrics,18(1). doi:10.1186/s12877-018-0864-6
[3] Hattori, H., Hattori, C., Hokao, C., Mizushima, K., & Mase, T. (2011). Controlled study on the cognitive and psychological effect of coloring and drawing in mild Alzheimers disease patients. Geriatrics & Gerontology International,11(4), 431-437. doi:10.1111/j.1447-0594.2011.00698.x
[4] How Hobbies Impact Your Head and Your Heart. (n.d.). Retrieved from https://www.psychologytoday.com/us/blog/debunking-myths-the-mind/201706/how-hobbies-impact-your-head-and-your-heart
[5] How to Help a Person With Dementia Continue to Enjoy Their Hobbies. (2018, July 20). Retrieved from https://www.alzheimers.net/help-a-person-with-dementia-continue-to-enjoy-their-hobbies/
[6] Tomioka, K., Kurumatani, N., & Hosoi, H. (2016). Relationship of Having Hobbies and a Purpose in Life With Mortality, Activities of Daily Living, and Instrumental Activities of Daily Living Among Community-Dwelling Elderly Adults. Journal of Epidemiology,26(7), 361-370. doi:10.2188/jea.je20150153
[7] Yatczak, Jayne. “The Power of Ritual and Hobbies: Engaging in Favorite Pastimes Can Help People with Dementia .(Viewpoint Essay).” Generations (San Francisco, California), vol. 35, no. 3, 2011, pp. 71–73.

Acti-v8 Your Brain

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Acti-v8 Your Brain is a program that is designed to help individuals sustain a healthy brain! All of the information that each of the 8 pillars in the program provide is scientifically validated and geared towards ultimate brain wellness!

The 8 Pillars are as follows:

 1) Eat Well  – Maintain a healthy diet with plenty of fruits, vegetables, whole grains, and protein. Refer to last week’s blog post to see a chart of foods high in L-serine. These foods may boost your brain health as well. 

 2) Stay Active – Participate in regular physical activity. This will help clear the mind and make your body feel better. People who are regularly physically active typically feel better, sleep better, and have more energy.

3) Sleep Well – Sleep is a important for your body to heal and the mind to recharge for the next day. Make sure to get a good night’s rest because it can affect your memory and ability to pay attention. On our resources page of the Center for Cognitive Health website, you can find a link to Tuck Sleep. Their website has resources and information about sleep hygiene for seniors.

4) Exercise Your Brain – Remember to challenge your mind and engage in mentally stimulating activities. this can include reading, word games, puzzles, hobbies, playing music, learning something new etc.

 5) Connect With Friends And Family – Don’t forget to maintain a social life. Studies have shown that increased social activity is linked to a lower rate of cognitive decline. Plan time to spend with others or attend events that spark your interest and allow you to connect with others!

 6) Relax And Reduce Stress – Stress can be damaging to the brain and contribute to memory and thinking problems. Try activities such as deep breathing, yoga, art, music, mindfulness or meditation to help manage symptoms of stress and boost your health.

7) Control Risk Factors – Other medical conditions can put you at risk such as obesity, diabetes, depression and hypertension. Make sure to manage symptoms of any medical conditions you are experiencing as they may contribute to a decline in your cognition.

8) Get Involved In Research – Since no cure exists for Alzheimer’s disease, it is important to know of research opportunities that are actively recruiting participants. Clinical research can offer patients who are diagnosed with Alzheimer’s a proactive approach to sustaining brain functioning and warding off Alzheimer’s disease symptoms. Clinical research studies provide in-depth examinations of the patient’s symptoms and access to experimental treatments that will help us find a cure. Because of the hesitancy around participating in clinical research, ninety percent of Alzheimer’s clinical trials in the United States are delayed because they experience trouble finding clinical trial participants.

 Find a research study that is a good fit for you and help us better understand how this disease can be treated. Clinical trial research opportunities at the Center for Cognitive Health can be found on our website here. Keep checking back as new studies may be added from time to time. You can also call us regarding research opportunities or for more information at 503-548-0908.

The 8 pillars identified above are areas of lifestyle that should be well maintained in order to help reduce your risk of cognitive decline as you age. It is recommended to use a combination of all 8 pillars to maximize the potential benefits of the Acti-v8 Your Brain Initiative.

More information can be found about Acti-v8 Your Brain here via memorystrings.org. Articles related to Acti-v8 Your Brain can be found here.

Another article worth reading about Pillar #8 can be found here. 

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Sources: 
Acti-v8 Your Brain [Internet]. Memory. [cited 2019Apr1]. Available from: https://memorystrings.org/activ8yourbrain
https://www.nj.com/healthfit/2019/03/8-ways-to-reduce-your-risk-of-alzheimers-and-maybe-help-researchers-find-a-cure-faster.html
Interactive N. Press Room [Internet]. Global Alzheimer’s Platform Foundation. [cited 2019Apr1]. Available from: https://gapbeta.org/resources/press-room/
Logo Photo: https://memorystrings.org/activ8yourbrain

Looking At The Use Of L-serine and Potential Health Benefits/Risks

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Researchers are looking into a new theory that may lead to a different approach in the treatment of Alzheimer’s disease. Recently on our Facebook page we shared an article about L-serine and the role that it may play on the prevention of Alzheimer’s disease and ALS. (The article can be found here. ) Paul Cox PhD, describes that “L-serine appears to be neuroprotective against all possible protein misfolding. It basically turns on a system in our brains that looks for unfolded proteins and is quickly poised to act on them.” He theorizes that L-serine “could significantly delay the onset of Alzheimer’s and the progress of its symptoms.”[6]

There is currently a Phase II clinical trial underway investigating the Effects of L-serine on Early Stage Alzheimer’s Disease Patients. Specific details of this trial can be found here. 

While reading about the research being done, I found myself wondering: What should consumers be aware of when buying this product? Is it safe? What are the risks? How do we even use it? Can you only get L-serine in supplement form? Here is what I found.

What is L-serine?

“L-serine is an amino acid essential for the synthesis of phosphatidylserine, which is a component of the membrane of brain cells (i.e., neurons).”[1]  It can be produced naturally in the body, but it can also be introduced into your body by the foods you eat or as a dietary supplement.

Are L-serine supplements safe? Have any risks been identified?

L-serine in dietary supplement form is identified as a “Generally Regarded As Safe” (GRAS) supplement compounded by the FDA. Research on the benefits and risks of L-serine on the body is still very new, and further research is needed to identify the effects of having too little or too much L-serine in the body. Always talk with your healthcare provider before adding any new supplements into your routine.

How do I use an L-serine supplement?

L-serine can be purchased in a capsule or powder form. There are many different brands available, and it is easily found in drug stores or online. That being said, it’s very important to do your research and make sure you are purchasing your supplements from a reputable source. The current Phase II clinical trial is administering L-serine in a gummy form, but those are not approved for over-the-counter sale at this time.

What should I look out for when shopping for products like this?

I mentioned earlier the importance of purchasing dietary supplements from reputable sources. The FDA has created a great page with resources for dietary supplement consumers, there is also a page for older dietary supplement users. Both pages provide information such as: Basic points to consider, tips for searching on the web, other tips and to-do’s, and how to spot fake or mismarketed products. Taking a look at this information will help you make informed decisions if you are considering the addition of new supplements to your daily routine. These pages can be found here  and here.

Are there other ways to increase L-serine without buying it as a dietary supplement?

Yes! There are many foods that are naturally high in L-serine. For those of you that would rather not add another supplement into the mix, here are some foods that are naturally high in L-serine.

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Sources:
1. L-Serine [Internet]. Alzheimer’s Drug Discovery Foundation. [cited 2019Mar25]. Available from: https://www.alzdiscovery.org/cognitive-vitality/ratings/l-serine#safety-block
2. Phase IIa L-serine Trial for eAD – Full Text View [Internet]. Phase IIa L-serine Trial for eAD – Full Text View – ClinicalTrials.gov. [cited 2019Mar25]. Available from: https://clinicaltrials.gov/ct2/show/NCT03062449
3. Center for Food Safety and Applied Nutrition. Information for Consumers – Tips for Dietary Supplement Users [Internet]. U S Food and Drug Administration Home Page. Center for Food Safety and Applied Nutrition; [cited 2019Mar25]. Available from: https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm110567.htm
4. What Is L-Serine and What Is Research Telling Us? [Internet]. Healthy Concepts with a Nutrition Bias. 2018 [cited 2019Mar25]. Available from: http://blog.naturalhealthyconcepts.com/2016/12/05/l-serine-als-research/
5. Center for Food Safety and Applied Nutrition. Information for Consumers – Tips for Older Dietary Supplement Users [Internet]. U S Food and Drug Administration Home Page. Center for Food Safety and Applied Nutrition; [cited 2019Mar25]. Available from: https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm110493.htm
6. Could This Radical New Approach to Alzheimer’s Lead to a Breakthrough? [Internet]. Fortune. [cited 2019Mar25]. Available from: http://fortune.com/longform/alzheimers-disease-cure-breakthrough/

FDA Cites 17 Companies For Illegally Marketing Dietary Supplements as Treatments For Dementia

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For many ailments and conditions, over-the-counter products are readily available to help consumers find relief or treat various medical symptoms. When it comes to the relief and treatment of Alzheimer’s disease, there are many false claims being advertised about products that can “cure” the disease. This form of deceptive advertising is misleading vulnerable consumers to purchase fake treatments, and encouraging them to waste money on treatments that have not been properly reviewed by the FDA. “Brain health supplements make up more than $3 billion of the global market, and are predicted to reach $5.8 billion by 2032” (ALZFORUM, 2019).  Why? Because consumers are fearful of developing dementia and experiencing cognitive decline, while others are looking for ways to increase cognitive performance at work or school.

According to ALZFORUM, the press release made by the FDA on February 11, 2019 accused 17 companies of illegally marketing their products as dementia treatments. The supplements included vitamins, minerals, and herbal products. These products are unapproved or misbranded new drugs that claim to prevent, treat or cure Alzheimer’s disease and other serious health conditions. Selling them with this misbranding is in violation of the Federal Food, Drug, and Cosmetic Act. The FDA press release can be found here. The full ALZFORUM article can be read here. 

Several prescription drugs have been approved by the FDA for the treatment of people with an Alzheimer’s disease diagnosis such as: donepezil (Aricept®), rivastigmine (Exelon®), galantamine (Razadyne®), and memantine (Namenda®) (National Institute on Aging, 2016).  None of these drugs can cure or reverse the disease, but may provide symptom relief.

Clinical trials research is required for the FDA approval of new drugs to make sure they are effective and safe. To see what research opportunities are currently being offered at the Center for Cognitive Health, please fill out the How Can We Help You section at the bottom of this page or call (503) 548-0809. You may meet the criteria needed to help us test the efficacy of new drugs. 

To learn more about protecting yourself from fake treatments, take a look at this article provided by the FDA for consumers.

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Sources:
Alzheimer’s Disease Fact Sheet [Internet]. National Institute on Aging. U.S. Department of Health and Human Services; [cited 2019Mar15]. Available from: https://www.nia.nih.gov/health/alzheimers-disease-fact-sheet
 
Dementia Researchers Commend FDA Crackdown on Supplement Hype [Internet]. ALZFORUM. [cited 2019Mar15]. Available from: https://www.alzforum.org/news/community-news/dementia-researchers-commend-fda-crackdown-supplement-hype
 
Office of the Commissioner. Press Announcements – FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease [Internet]. U S Food and Drug Administration Home Page. Office of the Commissioner; [cited 2019Mar15]. Available from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631064.htm
 
Office of the Commissioner. Consumer Updates – Watch Out for False Promises About So-Called Alzheimer’s Cures [Internet]. U S Food and Drug Administration Home Page. Office of the Commissioner; [cited 2019Mar15]. Available from: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm631046.htm

Amyloid PET Identifies Those At Risk For Alzheimer’s Disease

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Michael Mega, MD, PhD Director, Center for Cognitive Health

        The definition of Alzheimer’s disease is changing. With the ability to visualize beta amyloid, the predominate protein that makes up the plaques in Alzheimer patient’s brains, physicians now can tell who is at risk for the disease. Prior to the advent of amyloid PET scans, and spinal fluid analysis of beta amyloid, the certain diagnosis of Alzheimer’s disease was only made at death by microscopic evaluation of amyloid plaque burden. Now with the ability to visualize amyloid burden in life we have a window on how the disease evolves.

Alzheimer’s disease was once defined as a clinical presentation of a memory disorder with a decline in another domain of thinking (either language, visual-spatial processing, or problem solving) that is severe enough to interfere with daily functioning. Although many brain diseases can interfere with daily functioning to cause “dementia,” Alzheimer’s disease is the number one cause of dementia. Using this old definition of Alzheimer’s disease, investigators found that 15-20% of patients had o amyloid deposited in their brains on Amyloid PET scans. These patients may have diluted the findings in clinical trials testing amyloid lowering agents that hoped to slow or stop the disease. For this reason the definition of Alzheimer’s disease has moved from the old clinical description to a biological diagnosis. Now a person can only have Alzheimer’s disease when they are found to have an abnormally high amount of amyloid in their brain.

We all produce beta amyloid in our brains. Those of us who develop Alzheimer’s disease either make too much amyloid or do not clear it properly. Amyloid PET scans have shown the beginnings of amyloid accumulation in people as young as 30 to 40 years old. When a cognitively normal person has an abnormally high amount of amyloid in their brain they are now said to have preclinical Alzheimer’s disease; if they have a slight memory problem they meet the definition of prodromal Alzheimer’s disease, when their memory and thinking dysfunction is severe enough to interfere with daily life they are said to have full-blown Alzheimer’s dementia.

Selective amyloid lowering agents appear not to work in full-blown Alzheimer’s dementia. Can these new drugs work in the earlier stages of the disease in people with positive Amyloid PET scans? That is a question that our aging society is waiting to answer.  

Photo Caption:

Amyloid PET scans show amyloid deposits in red in the brains of people with Alzheimer’s disease. A&B) Patients scanned at screening and after 78 weeks of treatment with the selective amyloid lowering agent: bapineuzumab, note the reduction in amyloid deposition. C&D) Patients given placebo in the same study, note increased accumulation of amyloid in their brains.

How to Lower Your Risk for Alzheimer’s Disease

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Michael Mega, MD, PhD Director, Center for Cognitive Health

Do you have a family history of Alzheimer’s disease? If you do there is much you can do now to reduce the chances of developing the disease even if you are carrying genes that increase your risk. Your lifestyle can turn on genes that fight disease and turn off those that increase the risk for disease. We are just beginning to understand that the foods we eat, our physical activity, how we deal with stress, and the cognitive stimulation we receive from our work or pastimes can influence our risk for developing Alzheimer’s disease.

Reducing many of the risks for cardiovascular disease also reduce the risk for Alzheimer’s disease. The food we eat can be medicine, or poison. The most harmful “food” we consume is refined sugar. The higher our daily dose of this manmade poison the greater our risk for developing obesity, diabetes, stroke, heart attack, and Alzheimer’s disease. Embracing a Mediterranean diet low in simple carbohydrates and high in fruits, vegetables, nuts, olive oil, and seafood is associated with a reduction of Beta-amyloid, the protein thought to cause Alzheimer’s disease (see figure below.)

Increasing our physical activity with aerobic exercise by as little as 20 minutes every other day has been associated with improvements in cognitive testing in patients with Mild Cognitive Impairment (MCI), a condition thought to be prodromal Alzheimer’s disease when Beta-amyloid is abnormally high in the brain. Stress, or administration of the stress hormone glucocorticoid, increases Beta-amyloid and the protein that makes up the microscopic tangles in the brain involved in synaptic dysfunction and neuronal death associated with Alzheimer’s disease. Thus, stress reduction through mindfulness, biofeedback, and yoga can reduce disease risk.

Learning new information increases the density of the connections, or synapses, between brain cells; these synapses are pruned early in the disease. Increased synaptic density, occurring through cognitive stimulation increases our cognitive reserve. The higher our cognitive reserve the lower our risk for developing Alzheimer’s disease. So if you don’t use it you will loose it. Now is the time to modify your lifestyle to prevent Alzheimer’s even if you have a history of the disease.

Photo Caption:  Amyloid PET scans showing two-year increase in amyloid deposits in the brains of 36 cognitively healthy people who did not adhere to a Mediterranean diet compared to 34 who did adhere to the diet. These data support a 1.5-3.5 year protection against Alzheimer’s disease when people follow a Mediterranean diet for only 2-3 years. (Berti, V et al. Neurol 2018; 90:e1798) 

Our Research

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In the quest to conquer Alzheimer’s disease, new drugs that can be used long before the effects of the disease take hold are being tested. These drugs can target and diminish production of a specific protein found in the brain – Beta-amyloid – that’s thought to cause Alzheimer’s.

“The field of Alzheimer’s care has changed significantly in recent years,” says Michael Mega, M.D., Ph.D. Mega is a Cognitive Neurologist and founder of the Center for Cognitive Health in Portland. “Science is no longer testing people with full-blown Alzheimer’s, because it’s known that anti-amyloid drugs don’t work when the disease is that advanced.

The Center for Cognitive Health is participating in clinical trials testing new drugs to treat the early stages of memory problems associated with Alzheimer’s.

It’s long been hypothesized that Beta-amyloid plaques, the sticky buildup surrounding neurons in the brain, are the cause of Alzheimer’s.

“The emergence of Amyloid-PET (Positron Emission Tomography) enables the amyloid plaque to be visualized in the living brain,” says Mega. “It allows us to select people who are at risk to develop Alzheimers disease, and then administer these anti-amyloid compounds to see if we can slow cognitive decline.”

The biological purpose of amyloid protein is not well understood. “Some data indicate that a byproduct of its production helps the “pruning” process during the first year of life,” says Mega, who’s worked in the cognitive health field for 27 years. “That’s a time when neurons not being used for sensory perception are “pruned” to allow others being used to become stronger.”

Amyloid, and other misfolded proteins, appears to be cleared from the brain during REM sleep as a form of daily de-toxing. Hence, there’s a theory that REM sleep abnormalities are a precursor to Alzheimer’s, Parkinson’s and other degenerative diseases.

Because amyloid deposits in the brain appear to peak about 10 years before memory symptoms occur, scientists are committed to determining when anti-amyloids should best be administered.

Keep an eye out for new research opportunities being offered at the Center for Cognitive Health!