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Joel S. Ross, MD, FACP, AGSF, CMD President and Founder of Memory Enhancement Center of America
 

Joel S. Ross, MD
MD FACP AGSF CMD CPI
President and Founder
 
Memory Enhancement Center
of America, Inc.
4 Industrial Way West, 2nd Floor
Eatontown, New Jersey 07724
732.571.1535
 

Dimebon a failure in the treatment of Alzheimer’s Disease patients

By Joel Ross | March 5, 2010

“The Alzheimer’s Association is disappointed to learn of the negative results from the Phase III clinical trial of latrepirdine (Dimebon),” said William Thies, Ph.D., Alzheimer’s Association Chief Medical and Scientific Officer. “People with Alzheimer’s, their families and caregivers desperately need more and better treatment options for this devastating, fatal brain disease.”

Nonetheless, the Alzheimer’s Association remains optimistic about the future prospects for better Alzheimer’s treatments and prevention strategies. Several dozen other compounds are in the pipeline for Alzheimer’s disease. We remain encouraged by the fact that drugs in the pipeline for Alzheimer’s attack the disease from a variety of angles.

“The population is aging, and we need to make significant advances soon in the treatment and prevention of Alzheimer’s. It is an overwhelming epidemic, already claiming millions of individuals, and it is on track to deplete our healthcare resources and devastate Medicare,” Thies said. “The current level of federal research funding for Alzheimer’s is unacceptable considering the many millions of people this disease affects and the huge financial impact on our economy and society. And, these numbers will grow exponentially with the aging of our population.”

According to the Association, in order to get better diagnosis, treatments and prevention for Alzheimer’s, we must address two important issues.

1. We must address the chronic underinvestment in research to ultimately solve the Alzheimer crisis. We need to get more Alzheimer drugs in the pipeline. To do this, we must increase the research investment in Alzheimer’s to levels similar to other leading causes of death, such as cancer and heart disease. Only then will we have the chance to see the same type of progress such as declining death rates, and viable lifestyle-based prevention strategies stop this epidemic. If we do not invest now, the cost of Alzheimer’s disease to taxpayers in Medicare and Medicaid costs will be $20 trillion dollars over the next 40 years equal to 25 economic stimulus bills.

2. In addition to increasing funding, it is imperative that people volunteer for Alzheimer’s clinical trials. Later this year, at the Alzheimer’s Association 2010 International Conference on Alzheimer’s Disease (ICAD) the Association is planning to launch a first of its kind tool to help match people with Alzheimer’s and caregivers with Alzheimer’s clinical trials.

Source: Alzheimer’s Association

Topics: Uncategorized | No Comments »

Real World Study of FDA approved Alzheimer’s Disease Drugs: Pause for ?Concern

By Joel Ross | February 4, 2010

In the many years I have been working with pharmaceutical testing of new AD compounds, the real world benefit of the below mentioned drugs has always been a very important question.  Perhaps now my readers will see a different slant of the benfits/risks of such meds.  I report the below article for my readers to simply understand the differences between clinical research setting/testing of AD drugs vs. the “real world” testing of AD drugs outside of the pharmaceutical sponsored study.   These drugs do work for some and not for others.

Effects of Donepezil, Galantamine and Rivastigmine in 938 Italian Patients with Alzheimer’s Disease: A Prospective, Observational Study

Santoro, Aurelia; Siviero, Paola; Minicuci, Nadia; Bellavista, Elena; Mishto, Michele; Olivieri, Fabiola; Marchegiani, Francesca; Chiamenti, Andrea Maria; Benussi, Luisa; Ghidoni, Roberta; Nacmias, Benedetta; Bagnoli, Silvia; Ginestroni, Andrea; Scarpino, Osvaldo; Feraco, Emidio; Gianni, Walter; Cruciani, Guido; Paganelli, Roberto; Iorio, Angelo Di; Scognamiglio, Mario; Grimaldi, Luigi Maria Edoardo; Gabelli, Carlo; Sorbi, Sandro; Binetti, Giuliano; Crepaldi, Gaetano; Franceschi, Claudio

Abstract

Background: Acetylcholinesterase inhibitors (AChEIs) have been used to improve cognitive status and disability in patients with mild to moderate Alzheimer’s disease (AD). However, while the efficacy of AChEIs (i.e. how they act in randomized controlled trials) in this setting is widely accepted, their effectiveness (i.e. how they behave in the real world) remains controversial.

Objective: To compare the effects of three AChEIs, donepezil (Aricept®), galantamine (Reminyl®) and rivastigmine (Exelon®), in an Italian national, prospective, observational study representative of the ‘real world’ clinical practice of AChEI treatment for AD.

Methods: 938 patients with mild to moderate AD collected within the framework of the Italian National Cronos Project (CP), involving several UVAs (AD Evaluation Units) spread over the entire national territory, who were receiving donepezil, galantamine or rivastigmine were followed for 36 weeks by measuring: (i) function, as determined by the Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scales; (ii) cognition, as measured by the Mini-Mental State Examination (MMSE) and the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) [primary outcome measures]; and (iii) behaviour, as measured on the Neuropsychiatric Inventory (NPI) and Clinical Dementia Rating (CDR) scale. Moreover, all patients were genotyped for apolipoprotein E (apoE) genetic variants.

Results: No statistically significant improvement in the primary outcome measures (MMSE and ADAS-Cog) was observed with drug therapy at 36 weeks, at which point all groups had lost, on average, 1 point on the MMSE and gained 2–3 points on the ADAS-Cog scale compared with baseline. On the secondary outcome measures at week 36, all treatment groups showed a significant worsening on the ADL and IADL scales compared with baseline, while on the NPI scale there were no significant differences from baseline except for the galantamine-treated group which worsened significantly. Moreover, patients receiving galantamine worsened significantly compared with the donepezil-treated group on the IADL scale. ApoE ϵ4 allele did not influence the effect of drug therapy.

Conclusion: Over a 36-week follow-up period, no significant difference in the effects of donepezil, galantamine and rivastigmine on a variety of functional and cognitive parameters was observed in a large number of apoE-genotyped patients with mild to moderate AD recruited within the framework of a national project representative of the scenario usually encountered in actual clinical practice in Italy. The limitations (possibility of administration of lower drug doses than are used in clinical trials, relatively short follow-up period and the lack of randomization) and strengths (large number of patients, concomitant observation of the three drugs and the number of parameters assessed, including apoE genotype) of the present study are acknowledged. Our type of naturalistic study should complement clinical trials because ‘real world’ practice operates in the face of the numerous variables (e.g. health status and co-morbidities) associated with a complex disease such as AD in elderly people.

Copyright 2010 Adis Data Information BV

Topics: Uncategorized | 4 Comments »

Even minor memory lapses could be significant!!!

By Joel Ross | January 11, 2010

Senior moments?   Age related memory loss?  Should you worry?  Maybe so. Read below!

Healthy older adults with subjective memory loss may be at increased risk for MCI and dementia

Forgot where you put your car keys? Having trouble recalling your colleague’s name? If so, this may be a symptom of subjective cognitive impairment (SCI), the earliest sign of cognitive decline marked by situations such as when a person recognizes they can’t remember a name like they used to or where they recently placed important objects the way they used to. Studies have shown that SCI is experienced by between one-quarter and one-half of the population over the age of 65. A new study, published in the January 11, 2010, issue of the journal Alzheimer’s & Dementia, finds that healthy older adults reporting SCI are 4.5 times more likely to progress to the more advanced memory-loss stages of mild cognitive impairment (MCI) or dementia than those free of SCI.

The long-term study completed by researchers at NYU Langone Medical Center tracked 213 adults with and without SCI over an average of seven years, with data collection taking nearly two decades. Further cognitive decline to MCI or dementia was observed in 54 percent of SCI persons, while only in 15 percent of persons free of SCI.

“This is the first study to use mild cognitive impairment as well as dementia as an outcome criterion to demonstrate the outcome of SCI as a possible forerunner of eventual Alzheimer’s disease,” said Barry Reisberg, MD, professor of psychiatry, director of the Fisher Alzheimer’s Disease Program and director, Clinical Core, NYU Alzheimer’s Disease Center at NYU Langone Medical Center. “The findings indicate that a significant percentage of people with early subjective symptoms may experience further cognitive decline, whereas few persons without these symptoms decline. If decline does occur in those without SCI symptoms, it takes considerably longer than for those with subjective cognitive symptoms.”

According to the authors, scientists and physicians can now target the prevention of eventual Alzheimer’s disease in the SCI stage, beginning more than 20 years before dementia becomes evident

“These intriguing results more fully describe the possible relationship between early signs of memory loss and development of more serious impairment. This is critical to know, as we look for ways to define who is at risk and for whom the earliest interventions might be successful,” said Neil Buckholtz, PhD, National Institute on Aging (NIA) which supported the research. “These findings also underscore the importance of clinicians’ asking about, and listening to, concerns regarding changes in cognition and memory among their aging patients.

Co-authors of Dr. Reisberg at the NYU Alzheimer’s Disease Center include Melanie B. Shulman, MD, Carol Torossian, PsyD, and Wei Zhu, PhD.

Primary funding for this study was provided by the NIA, which is part of the National Institutes of Health. Additional funding was provided by Mr. Leonard Litwin and the Fisher Center for Alzheimer’s Research Foundation.

About NYU Langone Medical Center

 

NYU Langone Medical Center is one of the nation’s premier centers of excellence in healthcare, biomedical research, and medical education. For over 168 years, NYU physicians and researchers have made countless contributions to the practice and science of health care. Today the Medical Center consists of NYU School of Medicine, including the Smilow Research Center, the Skirball Institute of Biomolecular Medicine, and the Sackler Institute of Graduate Biomedical Sciences; the three hospitals of NYU Hospitals Center, Tisch Hospital, a 705-bed acute-care general hospital, Rusk Institute of Rehabilitation Medicine, the first and largest facility of its kind, and NYU Hospital for Joint Diseases, a leader in musculoskeletal care; and such major programs as the NYU Cancer Institute, the NYU Child Study Center, and the Hassenfeld Children’s Center for Cancer and Blood Disorders.

Topics: Dementia | No Comments »

Will Dimebon be the next FDA approved Drug for AD?

By Joel Ross | January 11, 2010

I have been very actively researching Dimebon in clinical research studies under strict FDA and industry guidelines, and saw the below article and felt my readers would be most interested in learning more about an “outsider” looking in at the potential for this drug if FDA approved for Alzheimer’s Disease.

For the Treatment of Alzheimer’s Disease, Pfizer/Medivation’s Dimebon Will Garner Peak Year Sales of $1.5 Billion

Clinical Trial Results Could Promote the Use of Dimebon Throughout the Course of Alzheimer’s Disease, According to New Findings from Decision Resources

Press Release Source: Decision Resources On Monday January 11, 2010, 8:00 am EST

WALTHAM, Mass., Jan. 11 /PRNewswire/ — Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, if Pfizer/Medivation’s Dimebon shows efficacy in two ongoing clinical trials in moderate to severe Alzheimer’s disease that is equivalent to the impressive clinical trial data it has already shown to date in mild to moderate patients, these positive data would promote the use of Dimebon throughout the course of the disease. As a result, following its expected launch in 2012, Dimebon will garner peak year sales of $1.5 billion in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

The Phase III CONTACT clinical trial for patients with moderate-to-severe Alzheimer’s disease will investigate the effect of Dimebon on neuropsychiatric symptoms and activities of daily living in patients who are already receiving a stable dose of donepezil (Eisai/Pfizer’s Aricept, Bracco’s Memac). The Phase III CONSTELLATION clinical trial will investigate slightly different end points: the effect of Dimebon on cognition, memory and activities of daily living in patients already receiving a stable dose of memantine (Merz/Grupo Grunenthal’s Axura/Akatinol, Lundbeck’s Ebixa, Forest Laboratories’ Namenda).

The Pharmacor finding from the topic entitled Alzheimer’s Disease also reveals that, through 2018, robust 11 percent annual growth in the Alzheimer’s disease drug market will be driven by the launch and uptake of new anti-amyloid monoclonal antibodies, most notably Johnson & Johnson/Pfizer’s bapineuzumab and Eli Lilly’s solanezumab.

“Although monoclonal antibodies are expected to offer superior efficacy over other drugs in the market, their uptake will be initially slow following their launches, owing to potential safety concerns,” said Decision Resources Analyst Matthew Winton, Ph.D. “Nevertheless, bapineuzumab and solanezumab will achieve combined sales of nearly $6 billion in 2018.”

Topics: Alzheimer’s Disease, Clinical Research Study, Clinical Research Trials, Clinical Trials, Dementia | No Comments »

What’s the latest with “nutriceuticals” on memory loss?

By Joel Ross | January 11, 2010

Below is a nutriceutal approach to Alzheimer’s Disease.  Small study with interesting results.  The results will need to be replicated in a larger study of 1000 patients before I can be convinced of its true benefit to patients.

New approach to fighting Alzheimer’s shows potential in clinical trial

Nutrient mix shows promise in improving memory

CAMBRIDGE, Mass. — In the early stages of Alzheimer’s disease, patients typically suffer a major loss of the brain connections necessary for memory and information processing. Now, a combination of nutrients that was developed at MIT has shown the potential to improve memory in Alzheimer’s patients by stimulating growth of new brain connections.

In a clinical trial of 225 Alzheimer’s patients, researchers found that a cocktail of three naturally occurring nutrients believed to promote growth of those connections, known as synapses, plus other ingredients (B vitamins, phosopholipids and antioxidants), improved verbal memory in patients with mild Alzheimer’s.

“If you can increase the number of synapses by enhancing their production, you might to some extent avoid that loss of cognitive ability,” says Richard Wurtman, the Cecil H. Green Distinguished Professor of Brain and Cognitive Sciences, who did the basic research that led to the new experimental treatment. He is an author of a paper describing the new results in the journal Alzheimer’s and Dementia.

There is currently no cure for Alzheimer’s disease, though some medications can slow the progression of the disease. In particular, many U.S. patients take cholinesterase inhibitors, which increase levels of acetylcholine, a neurotransmitter important for learning and memory.

While those treatments target the symptoms of Alzheimer’s, Wurtman hopes to attack what he believes is the root cause of the disease: loss of synapses. The three nutrients in his dietary cocktail — uridine, choline and the omega-3 fatty acid DHA (all normally present in breast milk) — are precursors to the fatty molecules that make up brain cell membranes, which form synapses.

In animal studies, Wurtman has shown that these nutrients boost the number of dendritic spines (small outcroppings of neural membranes). When those spines contact another neuron, a synapse is formed.

Three additional clinical studies in Alzheimer’s patients are now underway, one in the United States and two in Europe. Results are expected to be available between 2011 and 2013.

The first clinical study was sponsored by the French company Danone, known in the United States as Dannon; the study was conducted primarily in Europe and was led by Philip Scheltens, director of the Alzheimer Center at Vrije Universiteit Medical Center in Amsterdam. Wurtman and MIT have patented the mixture of nutrients used in the study, and Nutricia Advanced Medical Nutrition, a unit of Danone, holds the exclusive license on the patent.

Patients with mild Alzheimer’s drank the cocktail (made in the form of a nutrient drink called Souvenaid, with the collaboration of Danone) or a control beverage daily for 12 weeks. Patients who received the nutrients showed a statistically significant level of improvement compared to control subjects: 40 percent of the treated patients improved performance in a test of verbal memory (memory for words, as opposed to memory of locations or experiences) known as the Wechsler Memory Scale, while 24 percent of patients who received the control drink improved their performance. Among those who received the cocktail, patients with the mildest cases of Alzheimer’s showed the most improvement.

The drink appeared to have no effect on patients’ performance in another commonly used evaluation for Alzheimer’s patients, the ADAS-cog test. Wurtman believes that is because ADAS-cog is a more general assessment that tests for orientation and movement/spatial memory as well as cognition. So in subjects with early Alzheimer’s who show principally cognitive changes, more than the 225 subjects in the first study will probably be required to yield significant ADAS-cog changes after Souvenaid. The 500 subjects in the ongoing study in the United States may be sufficient.

John Growdon, a neurologist at Massachusetts General Hospital, says that trying to regrow synapses is an innovative strategy and offers a complementary approach to two other lines of attack in treating Alzheimer’s: targeting the amyloid plaques that accumulate in patients’ brains, and minimizing the damage done by toxic metabolites that build up in Alzheimer’s-affected brains.

“I don’t think any one approach has a monopoly, and that’s good,” Growdon says. “You need to have a lot of different approaches because no one knows what’s going to work.”

Wurtman believes his approach to Alzheimer’s may eventually prove beneficial in treating other diseases. If these nutrients prove to be successful in Alzheimer’s patients, “then you can think about other diseases in which there are too few synapses,” such as Parkinson’s disease, he says. “There are a lot of diseases associated with synapse deficiency.”

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