Clinical Trials Archives

Souvenaid and Alzheimer’s Disease

Souvenaid, in its second clinical trial, has been proven to help the memory of people who suffer from mild Alzheimer’s disease (AD). Results of the trial were given at the 4th International Conference on Clinical Trials in Alzheimer’s Disease (CTAD) by Philip Scheltens, MD, PhD in San Diego in early November. Scheltens is head of the Alzheimer Center at the VU University Medical Center in Amsterdam.

Souvenaid has a unique mixture of nutrients that work by stimulating the connections between nerves, also known as synapses. Losing these connections is what many experts think is responsible for losing memory in Alzheimer’s patients.  Studies demonstrate that the nutrients in Souvenaid can help grow new synapses in the brain. People taking Souvenaid daily over three months had improved scores on memory tests.

Scheltens is cautiously optimistic about the new findings. More research needs to be done before any conclusions can be drawn, but he thinks it is a step in the right direction.

Souvenir II was completed at  27 centers in six countries in Europe to see if the effects from Souvenir I would last for eight weeks. This study used additional measures to test for recall and also measured brain activity. Of 259 subjects, over 91% finished the study.

Memory was tested at the beginning, at 12 weeks, and at 24 weeks. The composite score was gotten from the Rey Audtiory Verbal Test which tests instant recall, delayed memory, and recognition. The Wechlser Scale which tested verbal association was also used.

Over the 24 weeks, the total scores from the Souvenaid group were much higher than those from the control group. Besides just looking at memory scores, they are attempting to analyze the electroencephalogram and magnetoencephalogram data, which may help figure out the influence  Souveniad has on synapse building in patients with Alzehimer’s disease and dementia.

CTAD is sponsored by the University of California, San Diego School of Medicine and the European Alzheimer’s Disease Consortium (EADC).

Researchers at the Research Institute of the McGill University Health Centre (MUHC) have discovered a new blood test to diagnose Alzheimer’s disease (AD) which was published in the May issue of the Journal of Alzheimer’s Disease.  They have found a distinctive biochemical diagnosis in AD patients according to senior author Dr. Vassilios Papadopoulos.

Papadopoulos reports that post-mortem analysis of brain tissue has been the only definitive tool for AD. Now this clinical study shows that a non-invasive blood test based on a chemical process may be able to diagnose Alzheimer’s disease at an early stage and could be differentiated from other types of dementia.

This blood test is based on the production of a brain hormone called dehydroepiandrosterone (DHEA) which is present at high levels and has a wide range of biological effects. The researchers used a chemical process called oxidation to promote the production of DHEA in blood taken from non-Alzheimer’s patients. However, blood from AD patients did not produce an increase of DHEA.

The researchers were able to accurately and repetitively detect AD with small samples of blood. Although there are many possible therapies in clinical trials, there must first be an accurate diagnosis. Together with clinical findings, the blood test could be used to diagnose AD at a very early stage and the appropriate therapies could be monitored.

Source: MUHC Newsroom

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Hope for Alzheimer’s Disease

I know it’s difficult for families with an Alzheimer’s disease patient. What looks like so much promise for those of us who are candidates down the road, will not be a solution for those currently experiencing this dreadful disease. What’s available today are only five medications discussed previously here. These may slow down the progression of the disease, but they also have side effects (like most prescription medications) and are not permanent solutions. There are also many clinical trials going on. The Alzheimer’s Association is an excellent place to start your research.

This year there has also been a greater focus on caregivers because of organizations like the Alzheimer’s Foundation of America and celebrity involvement. Earlier this month, Al Roker of the Today show, hosted the first telethon, Together for Care, for the foundation. See video below.

Occasionally, we hear good news such as “New Piece of Alzheimer’s Puzzle Identified” which is very encouraging. Sometimes encouraging news turns out to be disappointing, but there’s always hope. In this new study, researchers from the Mayo Clinic in Rochester, Minnesota found that endothelial dysfunction increases production of proteins that provide the raw material for the amyloid plaques seen in the brains of people with Alzheimer’s disease. Simply put, endothelial dysfunction is a problem with the lining of the blood vessels. Read the full news release here.

So, as we turn the page to a new calendar year, let us keep the hope in our hearts. I wish all of you and your families a heart-warming new year.

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Alzheimer’s Disease: New Medicines in Development

Last week I told you about the Pharmaceutical Research and Manufacturers of America (PhRMA) and their report: 2010 Report: Medicines in Development for Alzheimer’s Disease. This report talks about how the biopharmaceutical research companies have nearly 100 medicines in development. Today there are 5 million Americans with Alzheimer’s disease and by 2050, the number is expected to jump to 13.5 million if no new medicines are found to prevent, delay or stop the progression of Alzheimer’s disease.

Currently there are only five medications on the market, but they are only temporary measures — they don’t work forever. The last one was approved in 2003 … that’s seven years ago. We have no vaccine available and in a post I wrote last month, they are still testing it on animals. According to the report, “America’s biopharmaceutical companies today have 98 medicines in the later stages of the pipeline, meaning they are either in clinical trials or awaiting FDA review.”

Furthermore, the report states:

Even modest progress can drastically change the trajectory, which some warn is like a “tsunami” headed our way. For example, a breakthrough that delays the onset of Alzheimer’s disease by just five years would mean a significant drop in the number of Alzheimer’s patients. Instead of 13.5 million Americans suffering from the disease in 2050, the number would be 7.7—only a little more than today. Overall, a treatment to delay onset by five years would save the health care system $447 billion.

Most important is the suffering that would be reduced for the families involved. Click here to read the full report.

Related to this was a roundtable discussion which I was invited to consisting of representatives from pharmaceutical companies Merck (David Michelson, MD), Pfizer (Phil Iredale, Ph.D.), and Eli Lilly (Richard Mohs, Ph.D.) PhRMA was represented by David Wheadon, MD and playwright Trish Vrandenburg of US Against Alzheimer’s who wrote The Apple Doesn’t Fall. Bloggers who participated besides myself included Lillie Ammann from A Writer’s Words, An Editor’s Eye and Joanne Reynolds of Blueprint for Caregiving. Click here to read Lillie’s summary. A transcript of the roundtable can be found here on PhRMA’s Web site.

To listen to researchers from Merck, Pfizer, and AstraZeneca, watch the video below.


Alzheimer’s Disease Vaccine

One thing that I’m hoping for more than anything else is that a vaccine be developed for Alzheimer’s disease (AD). Wouldn’t it be great if we could stop our brains developing anything worse than an occasional senior moment? A couple of weeks ago, it was reported that researchers at  UT Southwestern Medical Center, after seven years, have created an experimental vaccine against beta-amyloid, the small protein that forms plaques in the brain and is believed to contribute to the development of Alzheimer’s.

This new experimental vaccine stimulated more than 10 times as many antibodies that bind to and eliminate beta-amyloid as compared to similar so-called DNA vaccines that the UT Southwestern researchers tested in an animal study. There are several studies that have to be done including:

  • safety of the vaccine and
  • whether it protects the mental function in animals.

According to Dr. Roger Rosenberg, director of the Alzheimer’s Disease Center at UT Southwestern and senior author of the study,
“The antibody is specific; it binds to plaque in the brain. It doesn’t bind to brain tissue that does not contain plaque. “This approach shows promise in generating enough antibodies to be useful clinically in treating patients.”

There was another vaccine tested a couple of years ago from the University of Southampton where British researchers gave 64 patients with moderate Alzheimer’s disease an experimental vaccine designed to eliminate plaque from their brains. Some patients were followed for up to six years.

Autopsies on seven patients who died of Alzheimer’s during the study showed that nearly all of the sticky beta-amyloid protein thought to be dangerous had been removed. But all patients still had severe dementia. So that was a disappointment. It will take a long time just to figure out what they need to target.

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A couple of weeks ago, I wrote a post on Alzheimer’s disease (AD) research and the need for volunteers. I had heard nurse practitioner, Alice Brown, from Georgetown University Medical Center speak on Research in Alzheimer’s Disease: Hope for the Future. She is part of the Memory Disorders Program at Georgetown. There are many such programs across the country. Click here for a list of others. At Georgetown alone, there are at least seven research trials for which volunteers are needed. By volunteers, they mean everyone, including normal people. The trend in research is to identify people at risk for developing AD before they even show symptoms of the disease. AD does not develop overnight and pathology is present in the brain long before any signs or symptoms appear.

Alzheimer’s disease is the third most expensive disease in the US after cancer and cardiovascular disease and the fifth leading cause of death in those over 65. But not counted in the cost is the hours and hours of caregiver burden. We also know that age is the biggest factor in AD, but after that the major risk is a positive family history of the disease. Offspring of an individual with AD have a higher risk of getting AD as they age — about 30% compared to 10% of the general population of the same age.

Here is what current research is targeting:

  • Immune system — rid the body of toxic beta amyloid protein that form plaques (a known cause of AD)
    • Vaccines that allow the body to develop its own antibodies (active immunity)
    • Infusions that provide the body with antibodies within the infusion (passive immunity)
  • Brain repair — Nerve Growth Factor
    • Targets microglia — immune cells in the brain — to reproduce and repair the damage caused by beta amyloid
  • Inflammation — presumes inflammatory changes produce cell death and neuronal loss
  • Biomarkers – to help predict who may or may not develop AD and helps determine earlier targets for therapy
    • Cerebral spinal final (spinal tap — LP)
    • Imaging (MRI and PET)
  • Diabetes — questions regarding the role of insulin in brain function and metabolism

Brown stressed that the greatest barrier to progress in research is not enough volunteers and getting people to the location where the study is being conducted. If a study can’t recruit enough subjects or it takes a long time, then it will take longer to complete a trial and analyze results. Other problems are funding and the location of the study site.

For more information on the Georgetown program, check out this Web site — http://memory.georgetown.edu. In a future post, we will look at the exciting, new findings.

In three days, it will be 15 years since my father passed away. September also marks one year since I started this blog. It has opened my eyes (and my brain) to so many things. I’ve written about a variety of subjects, a number of them focused on research. Most recently, I got involved in a study at George Mason University (GMU). As a part of this study, I consented for them to do an MRI of my brain which they did last week. The anticipation of it all was more nerve-wracking than the procedure itself. The MRI machine at GMU is just for brain research and is smaller than the typical machine that is used for diagnosing other diseases and problems in hospitals and imaging centers.

Also last week, I went to a near-by assisted living facility where a nurse practitioner from Georgetown University Medical Center spoke on Research in Alzheimer’s Disease: Hope for the Future. Her talk will be the topic of another blog post, but one of the main difficulties that research studies are facing is the lack of participants. There are many research studies going on across the country. In a previous post on research, I mentioned a government Web site where you can look at some clinical studies recruiting for volunteers. Even the study that I’m in at George Mason University is looking for more subjects. Send me an e-mail for more information — info@aboutalz.com.

So if you’ve ever wondered if Alzheimer’s disease research needs volunteers, the answer is a resounding yes! It will not cost you anything except your time. You will be contributing toward understanding the staggering fact that every 70 seconds, a person is diagnosed with Alzheimer’s and with our aging population, the numbers will continue to rise. We must do all that we can to stop this and help find a cure!

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I saw an ad in a favorite little periodical I receive called the Golden Gazette. It’s published for senior adults in the county I live in. The ad read: Healthy Adults 40 & Older Needed for Research Study. That caught my attention. I read further:

The ARCH Lab at George Mason University, Fairfax campus, needs healthy adults age 40 to 65 to participate in behavior studies on memory and attention.

Bingo! I qualified age-wise and I’m definitely interested in anything related to memory. I e-mailed them immediately and was accepted into the longitudinal four-year study. There was a small monetary compensation, but I didn’t care about that. I was curious to see what the testing was about and if they are going to track me over a four-year period, then I’d definitely be interested in any changes that may occur.

The official name of the study is “Allelic Association to Study the Genetics of Cognitive Aging.” As defined by the Genetics Home Reference, an allele is one of two or more versions of a gene. An individual inherits two alleles for each gene, one from each parent. Click on the Genetics Home Reference link for more information.

According to the Consent Form that I signed, the research is being conducted to study the effect of normal variation in genes on processes of attention and memory in both healthy individuals and those at risk of developing Alzheimer’s disease. They hope to better understand the role of genetics in individual differences in attention and memory.

The test was comprised of several parts using the computer, paper and pencil, getting cheek cells for DNA analysis. An MRI would be done at a separate time, if one is interested.

Parts of the test were quite long which tested your attention span. Included in the computer test were the following:

  • A set of dot(s) flashed and you needed to determine if the second set of dot(s) was in the same position as the first.
  • A group of letters was presented and every time it included a pink “T” you needed to push a button.
  • Each time a vowel flashed you needed to push a button.

Included in the non-computer test were the following:

  • Puzzle completion
  • Repeating a story that was read
  • Vocabulary — defining words
  • You were read a series of mixed up letters and numbers and you needed to put them in order, numbers first (from memory)
  • Reciting numbers backwards by 7

Results of the study are for research only and the identity of the participants will not be revealed. Participation is voluntary and you can withdraw at any time. I’m glad to have George Mason University close by and to have the opportunity to participate.

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There’s been a lot of news about Alzheimer’s disease recently because of the annual meeting of the Alzheimer’s Association International Conference on Alzheimer’s Disease (AAICAD) which met from July 10 to 15, 2010 in Honolulu, Hawaii. The AAICAD is the world’s largest conference of its kind. It brought together almost 4,000 researchers from around the world to report and discuss groundbreaking research and information on the cause, diagnosis, treatment and prevention of Alzheimer’s disease and related disorders.

Alzheimer’s disease research continues to be under-funded, but this appears to be the most significant disease that the baby boomer generation will face. There were many interesting and significant items to come out of the conference, but I want to mention two of them because they immediately impact us. I mentioned in a previous post that participating in a clinical trial could prove to be very time-consuming, but if this is of interest to you, here is good news for you.

The Alzheimer’s Association announced the launch of Alzheimer’s Association TrialMatchTM, a confidential, free, and interactive tool that provides comprehensive clinical trial information and an individualized trial matching service for people with Alzheimer’s disease and related dementias. The Internet (www.alz.org/trialmatch) and phone-based (800-272-3900) program provides a first-of-its-kind service in Alzheimer’s by delivering individualized matches to clinical trials for people with Alzheimer’s, their healthcare professionals, caregivers, and healthy volunteers.

Second, we know that diet and exercise can play a role in either slowing down or reducing the risk of dementia. For example, adding turmeric to the diet (click here) might be beneficial.

Evidence from three long-term, large-scale studies (Framingham Study, Cardiovascular Health Study, NHANES III) supports the association of physical activity and certain dietary elements (tea, vitamin D) with possibly maintaining cognitive ability and reducing dementia risk in older adults. Plus, a new study in an animal model of Alzheimer’s reported today at AAICAD 2010 suggests that an antioxidant-rich diet with walnuts may benefit brain function. Research has pointed towards a number of factors that may impact our risk of Alzheimer’s and cognitive decline, the strongest being reducing cardiovascular risk factors. The Alzheimer’s Association and others have repeatedly called for longer-term, larger-scale research studies to clarify the roles that these factors play in the health of the aging brain. These studies from AAICAD 2010 are some of the first reports of this type in Alzheimer’s, and that is encouraging, but it is not yet definitive evidence.

Next year the group will meet in Paris, France from July 16-21. We look forward to more exciting news to come out of the meetings. For more research findings, click here.

ICAD 2011

Alzheimer’s Disease — Research

Research is one of the areas of Alzheimer’s disease (AD) of great interest to me. One of the best Web sites for this information is http://www.nia.nih.gov/alzheimers. This Web site is part of the Alzheimer’s Disease Education and Referral Center (ADEAR). Although the National Institutes of Health (NIH) is located in Bethesda, Maryland in the Washington, DC Metropolitan Area, there are studies going on across the country. In addition, there are research studies at all stages of Alzheimer’s. The NIH, known as The Nation’s Medical Research Agency, includes 27 institutes and centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research.

Through research, diagnoses of AD is becoming increasingly accurate. However, absolute certainly still requires an autopsy to define the plaques in the brain. Participation in these studies may require an autopsy where there is no charge to the family. However, if an autopsy is not acceptable to you or your loved one, then participating in research may not be something you should consider.

Participating in a research study could be very time consuming as well. It could involve commuting to the study site as well as filling out mounds of paper work. The specific drug in the drug trial may or may not work or it may work for awhile and then stop working so it’s better to keep your expectations low. Just remember to consider all aspects of  your life as a caregiver before signing up your loved one.

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