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.


Is there a link between the flu vaccine and Alzheimer’s disease? As I was researching the information in my last post for the Alzheimer’s vaccine, I stumbled across an article that stated:

According to Hugh Fudenberg, MD, the world’s leading immunogeneticist and 13th most quoted biologist of our times (nearly 850 papers in peer review journals), if an individual has had five consecutive flu shots between 1970 and 1980 (the years studied) his/her chances of getting Alzheimer’s Disease is ten times higher than if they had one, two or no shots. I asked Dr. Fudenberg why this was so and he said it was due to the mercury and aluminum that is in every flu shot (and most childhood shots).  The gradual mercury and aluminum buildup in the brain causes cognitive dysfunction.  Is that why Alzheimer’s is expected to quadruple? Notes: Recorded from Dr. Fudenberg’s speech at the NVIC International Vaccine Conference, Arlington, VA September, 1997.  Quoted with permission. Alzheimer’s to quadruple statement is from John’s Hopkins Newsletter Nov 1998.

That’s a pretty frightening statement for those of us really concerned about the future. On further investigation, I found that the South Carolina medical board found Fudenberg “guilty of engaging in dishonorable, unethical, or unprofessional conduct.” Click here for more information.

According to the Mayo Clinic, “there is absolutely no evidence that flu vaccines contribute in any way to Alzheimer’s disease, and it is hard to imagine a mechanism of how this could affect amyloid or tau.” The Canadian Medical Journal reported, “Past exposure to vaccines against diphtheria or tetanus, poliomyelitis and influenza may protect against subsequent development of Alzheimer’s disease.”

The bottom line is that you need to decide whether the flu shot is for you. If your immune system is very strong, you might not need it. On the other hand, if it’s compromised, then do some research and make your decision. To your health!

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Last week Reuters reported that international experts on Alzheimer’s disease (AD) are recommending that a new criteria for diagnosing Alzheimer’s should be used considering the recent scientific discoveries which includes the use of biomarkers (biological signals) which can determine if a person is at risk for developing the disease well before there are any symptoms. Hence, even as many as 10 years before any symptoms begin to show, it would be best to intervene. Recent studies have shown that brain scans, spinal fluid analyses, and other tests can possibly predict who will develop AD. With this knowledge, researchers and pharmaceutical companies can develop new drugs.

According to caring.com, the new criteria for diagnosing Alzheimer’s is much more accurate. It requires:

  • An early and significant episodic memory impairment
  • Gradual and progressive change of memory for more than 6 months
  • Objective evidence of recall memory that does not improve or does not normalize with adequate cueing or recognition testing

PLUS one or more of the following supportive features (the new early markers for increasing the specificity of a patient having AD):

  • Medial temporal atrophy on MRI
  • Abnormal spinal fluid concentrations of (1) amyloid, (2) total tau or (3) phospho-tau
  • Specific patterns of PET scanning producing hypometabolism of bitemporal parietal regions or Pittsburgh compound B
  • Proven AD autosomal dominant mutation within the immediate family

The criteria currently being used was adopted in 1984. In light of what the current research is showing, we are headed in the right direction to try to intervene as early as possible.

Most people did not believe Columbus when he said the world is round. Now in the world of Alzheimer’s disease research, Sam Gandy, M.D., Ph.D., Professor of Neurology and Psychiatry, and Associate Director of the Alzheimer’s Disease Research Center, Mount Sinai School of Medicine, has created quite a stir. He states, “The buildup of amyloid plaques was described over 100 years ago and has received the bulk of the attention in Alzheimer’s pathology. But there has been a longstanding debate over whether plaques are toxic, protective, or inert.”

So instead of the belief that brain cells are being destroyed by the sticky plaques, Gandy and his researchers think that there are free-floating clumps of protein that may be the culprit and that the sticky plaques may actually be protecting the body against these toxic clumps.

According to the Mount Sinai School of Medicine:

Several research groups had previously proposed that rather than plaques, floating clumps of amyloid (called oligomers) are the key components that impede brain cell function in Alzheimer’s patients. To study this, the Mount Sinai team developed a mouse that forms only these oligomers, and never any plaques, throughout their lives.

The researchers found that the mice that never develop plaques were just as impaired by the disease as mice with both plaques and oligomers. Moreover, when a gene that converted oligomers into plaques was added to the mice, the mice were no more impaired than they had been before.

This will take research in a new direction. Drugs that target plaques may not be of any help and could even make the disease worse.  Gandy works with specially engineered mice and William Thies, Chief Medical Officer, Alzheimer’s Association, warns us that the leap from mice to men is a long one and until Gandy’s experiments can be duplicated, drug companies will not be investing billios of dollars into creating new medication.

When Andrew Dillin, Ph.D., of the Salk Institute for Biological Studies started pursuing the oligomer theory several years ago, he said the the idea was so controversial that some scientists would walk out of the room when he made his presentations at conferences. Now, many top researchers are convinced.

More about oligomers and plaques in the next post.

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In September 2008, the International Journal of Geriatric Psychiatry published an interesting article: Smell test predicts performance on delayed recall memory test in elderly with depression. Who would’ve thought that a smell test might be a tool to forecast cognitive impairment. But it turns out that the elderly, particularly those diagnosed with depression, have an increased risk for cognitive dysfunction and dementia.

According to sensonics.com, Sensonics, Inc. tests can be used to detect smell loss but cannot be used alone to diagnose disease. Smell and taste monitor the intake into the body of all nutrients and airborne chemicals required for life.

Here is an abstract of the study that was done.

Purpose

To assess the validity of the CC-SIT (Cross-Cultural Smell Identification Test) as a screening test for cognitive impairment in elderly with depression.

Methods

Forty-one patients, aged 60 and over, were assessed with the CC-SIT and CVLT (California Verbal Learning Test) after three months of treatment of a Major Depressive Episode (DSM-IV) at the Day Hospital for Depression, Baycrest. Patients already diagnosed with dementia, or other psychiatric and neurological disorders, were excluded. Receiver Operating Characteristics (ROC) analysis was applied to assess the CC-SIT’s accuracy in identifying individuals with impairment (2 SD below the mean for age and education or less) on CVLT delayed recall trials.

Results

Forty-one patients (33 women and eight men) were assessed. Mean age was 76.8 (SD: 6.5), mean HRSD scores before treatment was 22.0 (SD: 5.1). Nine patients had impairment on CVLT delayed recall measures. The area under the ROC curve was 0.776 (95% CI = 0.617-0.936).

Conclusions

Our results support the use of the CC-SIT as a screening tool for cognitive impairment among elderly with depression as an indicator for the need of a comprehensive neuropsychological evaluation. Replication with larger samples is necessary. Copyright © 2008 John Wiley & Sons, Ltd.

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The American Journal of Alzheimer’s Disease and Other Dementias recently reported in an open-label pilot study that apple juice improved behavioral, but not cognitive symptoms in moderate-to-late Alzheimer’s disease patients. Although this was a very small study of only 21 institutionalized patients who drank two 4-ounce glasses of apple juice twice a day for a month, the study suggests that apple juice may be a useful nutritional supplement since, as Alzheimer’s disease (AD)  progresses, the mood of AD patients may decline as well. It may help ease the burden for caregivers.

The study said, “Caregivers reported an approximate 27% (P < .01) improvement in behavioral and psychotic symptoms associated with dementia as quantified by the Neuropsychiatric Inventory, with the largest changes in anxiety, agitation, and delusion.”

Exactly how apple juice might help remains unclear. It’s possible that the antioxidant nutrients in the apple juice reduces the oxidative damage to the brain tissue.

Since this was a very small study funded by the apple industry with no placebo, the conclusions need to be viewed with caution. However, given that apple juice is a healthy and inexpensive beverage, it would seem a positive thing for caregivers to try.

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Continuing my highlights of Alzheimer’s Care with Dignity by Frank Fuerst, in today’s post I list 6 caregiver products that Fuerst considers specifically helpful for people with dementia. You may be able to get them free or at a reduced cost. Ask your contacts such as members of your support group or see if it’s a Medicare-qualified item.

Consult his guide for a complete list, but the following are those that solved major physical and psychological challenges for him. Having gotten them sooner he feels would’ve prevented a good deal of stress.

  1. Bathroom transfer bench
  2. Geriatric chair
  3. Plastic runner
  4. Hand-held shower
  5. Stair lift
  6. Wheelchair

A bathroom transfer bench is one where two legs remain inside of the tub with suction cups and two legs are outside of the tub.  It comes with a backrest. Since the person remains seated while bathing, a hand-held shower works well. (Hand-held showers work well for cleaning the tub as well).

A geriatric chair is like a wheelchair except that it is larger and more comfortable. Get one with a tray that can swing down and out of the way.

Plastic runners will help to keep your carpet in good condition in case of accidents. They have spikes on the bottom to hold it in place. Not all plastic runners are alike even though they may look alike. Since you need to walk on the runner, a softer plastic might be more  comfortable than a stiffer one. Use them in areas where there are likely to be accidents such as from the bed to the bathroom and in eating areas.

Stair lifts are expensive, but might still be a less costly alternative to other home alterations. Fuerst suggests that you check the Internet. One source is http://silvercross.com for more information. They also sell used equipment and will buy back equipment, but don’t expect to recover much of your purchase price.

Finally, wheelchairs are available everywhere, but if you’ve never ridden in one, they are not exactly comfortable. Be sure to add a cushion, preferably a high quality gel cushion as mentioned in this post.

Caregiving at a Glance

The Alzheimer’s Family Day Center has a wonderful booklet for Alzheimer’s disease caregivers called Caregiving at a Glance. It’s designed with tabs that you can simply slip your finger under and get to the information you need. Sample topics covered include:

  • Sleeping
  • Bathing
  • Car and Home Safety
  • Activities … What to do Between Meals
  • Hostility and Aggression

On the topic of “Wandering,” for example, they suggest you register your loved one with the Safe Return program sponsored by the Alzheimer’s Association. You can call them toll-free at 1.888.572.8566 or on the Web at www.alz.org/safereturn.

“Troublesome Behaviors” is another section of this booklet. This covers a wide gamut, but they talk about things like screaming, repetitive phrases, or picking at clothes, tearing paper into tiny shreds, and other behaviors that develop in the middle to the late stages of the disease.

This wonderful resource is available at the Alzheimer’s Family Day Center by calling 703.204.4664 or e-mailing them at AFDC@alzheimersfdc@org.  The booklet is free – one copy per person. It was published with the permission of the Alzheimer’s Association. The project was supported, in part, by a grant from the Administration on Aging, Department of Health and Human Services, Washington, DC, 20201.

UCLA Ronald Reagan Medical Center

As stated in the previous post, today there are no reliable tests to determine conclusively if a person has Alzheimer’s disease (AD). However, there are several breakthrough tests on the horizon that have us hopeful that soon we may have an accurate test to diagnose Alzheimer’s disease. In the last post, I covered what’s happening at the Blanchette Rockefeller Neurosciences Institute (BRNI) at West Virginia University and Inverness Medical Innovations. In this post I will report on the breakthrough test for Alzheimer’s disease at the University of California at Los Angeles (UCLA).

At UCLA, researchers have developed a blood test that would measure the amount of amyloid beta that is being absorbed by immune cells in the blood. If the immune system isn’t adequately clearing amyloid beta, it may indicate Alzheimer’s risk. According to Gen News, the UCLA scientists took blood samples and isolated monocytes including amyloid beta. The monocytes were incubated overnight with amyloid beta, which was labeled with a fluorescent marker. Using flow cytometry, the investigators then measured the amount of amyloid beta ingested by the immune cells.

The 18 Alzheimer’s disease patients in the study showed the least uptake of amyloid beta. The healthy control group, which consisted of 14 university professors, had the highest uptake.

The method was able to distinguish the Alzheimer’s disease patients with adequate sensitivity and specificity and the results were found to be positive in 94% of patients and negative for the entire control group. Additionally, the data was positive in 60% of participants who suffered from mild cognitive impairment.

Milan Fiala, M.D., is the lead author of the UCLA study, which appeared in the May 2009 issue of the Journal of Neuroimmunology.

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Blanchette Rockefeller Neurosciences Institute

Today there are no reliable tests to determine conclusively if a person has Alzheimer’s disease (AD). However, there are several breakthrough tests on the horizon that have us hopeful that soon we may have an accurate test to diagnose Alzheimer’s disease. That’s a good thing. On an emotional level, though, sometimes I wonder if I really want to know. I prefer to not know and simply do all that I can to prevent it. (Click here for examples). There are several institutions and companies working on breakthrough tests and in this post I will cover what’s happening at the Blanchette Rockefeller Neurosciences Institute (BRNI) at West Virginia University and Inverness Medical Innovations.

At the Blanchette Rockefeller Neurosciences Institute (BRNI), the only non-profit independent institution in the world dedicated to the study of human memory and memory disorders, they located a biomarker that can be tested witout the invasive procedures previously required.  A biomarker is an objective, biological measure that is used to assess health or make a diagnosis of disease. The BRNI biomarker had a 98 percent level of accuracy in detecting AD. With the prick of a finger, it detects defective enzymes involved with memory function that are found in both brain and skin cells.

What is really exciting is that researchers discovered that low doses of the chemotherapy drug, bryostatin, reactivates the defective enzymes. It can actually rewire broken connections in the brain and restore memory! This means that it could be used to reverse the brain diseases. Clinical trials in people will start this year.