Saturday, December 30, 2006

Aricept: SIDE EFFECTS



 Adverse Events Leading to Discontinuation

The rates of discontinuation from controlled clinical trials of ARICEPT® due to adverse events for the ARICEPT® 5 mg/day treatment groups were comparable to those of placebo-treatment groups at approximately 5%. The rate of discontinuation of patients who received 7-day escalations from 5 mg/day to 10 mg/day, was higher at 13%.

Most Frequent Adverse Clinical Events Seen in Association with the Use of ARICEPT®

The most common adverse events, defined as those occurring at a frequency of at least 5% in patients receiving 10 mg/day and twice the placebo rate, are largely predicted by ARICEPT®’s cholinomimetic effects. These include nausea, diarrhea, insomnia, vomiting, muscle cramp, fatigue and anorexia. These adverse events were often of mild intensity and transient, resolving during continued ARICEPT® treatment without the need for dose modification.

Lisa write

Dear, Miranda Blowes. Mama : 80 years, Alzheimer's disease, the beginning of the ages five years ago, say that we certainly did not understand that it is dementia, clear signs of the eye 2 - 3 years ago, the disease progresses. At this point : often very aggressive, in this state may not sleep 2-e days, are increasingly deep fear, in these times Scams not come close (it is that we want to kill her), trying to run away from home. ... but generally, you all know the signs, cover them only because that very much looking forward to your advice about drugs Aricept, but there is a stage of disease, as far as I understand. How would you rate the medicine? I would be very grateful if you could reply. and another : whether to consult with you on the phone (if you have such services)? Sincerely, Lisa.

Dmitry write

doctor at home could not diagnose the illness which earlier in the hospital called depression, but now say that may dementia do not alzheimers prevention? the patient is brief and virtually silent and did not answer alzheimers cure, disease reaction and fear alzheimers statistics surplus. ... 

Hello! Asked the question on June 18 that is to see changes in the speech

Dany write:
Hello! Asked the question on June 18 that is to see changes in the speech (responsible Suponeva NA) to state that I am 30 years old. The only thing that I am concerned about the loss of hair, in this regard has already been about six months pass various surveys, but no pathology not. Yet I arthrosis hip joint, but I think it is unlikely due to my "reservations". Mother of 50 years, dementia may be linked as that. The vitamins, no drugs do not accept.
Dany Dec, 2006 1:30:43

Alzheimer's


The drug cuts build up of a key protein

Promising leads
Dr Sorenson said the results of the PBT2 study were one of many encouraging discoveries presented at last week's International Convention for Alzheimer's Disease which showed positive steps were being made towards finding new and better treatments.
Rebecca Wood, chief executive of the Alzheimer's Research Trust, said PBT2 was related to Clioquinol, an ointment used to treat skin infections such as athlete's foot.
She said "Scientists still have a lot of work to do before a drug could be available for patients.
"Much more research is needed even to see whether preventing the amyloid build-up is really a true benefit for patients.
"It would also be necessary to develop a drug that reduced the amyloid without removing it entirely, since a healthy brain still needs amyloid."

 

Save the Memory: new pill

They are called smart pills or brain boosters or, to use the preferred pharmaceutical term, cognitive enhancers.

But whatever the name given to compounds created to prevent or treat memory loss, drug companies and supplement producers - eager to meet the demands of a rapidly growing market 0 are scrambling to exploit what they view as an enormous medical and economic opportunity.


Three drugs being prescribed for Alzheimer's disease - donepezil (Aricept), galantamine (Reminyl) and rivastigmine (Exelon) - have been shown to delay somewhat the loss of mental abilities in people with the illness. So has the drug memantine, which has been used for years in Europe but has not been approved in the United States. Some experts also say that performing mental exercises and adding fish oil to the diet can delay memory decline.



Pharmaceutical companies are investigating dozens of other compounds to see whether they can help people who have memory difficulties but have not progressed to Alzheimer's. Some researchers hope that drugs will eventually prevent the deficits that even healthy elderly people experience. "The basic research into the causes of memory disorders is going very rapidly," said Dr. Solomon, who is also co-director of the Memory Clinic at the Southwestern Vermont Medical Center in Bennington.



But it will probably be at least five years before any of those drugs meet the standards for approval by the Food and Drug Administration, researchers said.



Clearly, the market for memory enhancers is growing with the aging of the population.



Dr. Steven T. DeKosky, a professor of neurology and psychiatry at the University of Pittsburgh School of Medicine, says he has noticed a marked increase in anxiety among baby boomers, who are watching their parents descend into Alzheimer's and hoping that new medicines will help them avoid the same fate.



"People in their 40's and 50's are saying: `How can you help my mother? And, by the way, how can I avoid this?' " Dr. DeKosky said. "Ten years ago, people wanted to know how frequently they should have their blood pressure checked and what sorts of food they should eat. Nobody ever asked what they should be doing to prevent themselves from getting a late-life dementia."



Even among those who are already suffering memory loss, Alzheimer's is far from the only source. An estimated four million Americans have it, but millions more suffer from other disorders that can lead to dementia, including Parkinson's disease, multiple sclerosis, stroke, head trauma and schizophrenia.

Experts estimate that an additional four million people have a syndrome called mild cognitive impairment, which may progress to Alzheimer's. People with the impairment can function on their own but have gaps in their memories.

Economic imperatives are also driving the search for new and better treatments for memory disorders.



The current cost of Alzheimer's alone runs $100 billion or more, said Dr. William Thies, vice president for medical and scientific affairs of the Alzheimer's Association, a research and support group.



If no new medications for memory disorders are found, Dr. Thies added, the number of Alzheimer's patients could quadruple by midcentury.



"That's going to bankrupt our health care system," he said. "So there's a need to find a way to short-circuit that impending disaster."



Except for extreme cases like advanced Alzheimer's, memory disorders do not generally disrupt what is often called procedural memory, the ability to perform basic tasks or motor skills like riding a bicycle or getting dressed.

Far more vulnerable is episodic memory, the ability to recall specific information about people, dates and events. Many of the new compounds being scrutinized seek to improve the way recent memories are stored, transformed into long-term memories and brought back into consciousness when needed.

Drugs approved specifically for Alzheimer's are being tested in patients who have mild cognitive impairment. But the medications can have side effects like nausea and diarrhea. So researchers are looking ahead to the second generation of memory enhancers, some of them now in clinical trials.

Some of the drug companies most involved in the search are small enterprises, focused on specific pathways or aspects of brain biochemistry. Memory Pharmaceuticals in Montvale, N.J., is developing compounds that maintain brain levels of a substance called cyclic AMP, which transmits intracellular signals and has been shown in mice to play a role in memory formation and retrieval.



Another company, Cortex Pharmaceuticals in Irvine, Calif., has two drugs in clinical trials that bind themselves to sites on nerve cells called AMPA receptors. The receptors respond to signals between cells carried by the neurotransmitter glutamate, and the drugs, called ampakines, are intended to enhance the strength of the incoming signal.



"It's like an amplifier to a stereo set, and you can turn up the volume of brain activity quite a bit by using these compounds," said Dr. Roger Stoll, president, chief executive and chairman of Cortex.



Despite optimism among neuroscientists about eventual success, few expect memory enhancers to be a panacea. Many researchers acknowledge that even if they find effective treatments, there is no guarantee that the drugs will do anything for people who age normally. Although some drugs have clearly enhanced the ability of animals to learn and perform routine tasks, that does not necessarily mean the same medications will help people remember names and faces, said Dr. Rodney Pearlman, president and chief executive of Saegis Pharmaceuticals in Half Moon Bay, Calif.


"It isn't clear that animals use the same kinds of memories that humans do," said Dr. Pearlman, whose company is developing several memory enhancers. "A mouse doesn't have to remember a PIN number to get along during the day."

 
Alzheimer's disease tends to develop slowly over time. If confusion and other changes in mental abilities come on suddenly, within hours or days, the problem may be delirium, a condition that needs immediate treatment.



Seek care immediately if:

Symptoms such as a shortened attention span, memory problems, or seeing or hearing things that aren't really there (hallucinations) develop suddenly over hours to days.

A person who has Alzheimer's disease has a sudden, significant change in normal behavior or if symptoms suddenly become worse.



Call your doctor to schedule an appointment if:

Symptoms such as a shortened attention span, memory problems, or false beliefs (delusions) develop gradually over a few weeks or months.

Memory loss and other symptoms begin to interfere with the person's work or social life or could result in injury or harm to the person.

You need help caring for a person with Alzheimer's disease.


 
Advanced Alzheimer's

The first drug found to be effective against the moderate to severe stages of Alzheimer's disease offers new promise for treating the illness at a time when patients and caregivers need it most.
The drug, called memantine, works in a novel way to prevent damage to brain cells, slowing the mental and physical deterioration seen in the later stages of the disease, according to the results of a large, well-designed study conducted at multiple major medical centers.


"This is a major breakthrough," says the study's lead author Barry Reisberg, M.D., professor of psychiatry and director of the Zachary and Elizabeth M. Fisher Alzheimer's Disease Education and Resources Program at New York University Medical Center. "Patients deteriorated about half as much as they otherwise would have over the six months of the study." The drug also appeared to be remarkably safe and free of side effects.



The later stages of Alzheimer's disease are a particularly stressful time for families and patients, who become increasingly unable to wash, bathe, and care for themselves. Currently available Alzheimer's drugs, such as Aricept, Exelon, and Reminyl, offer little benefit during this time. This new pill offers hope for millions with the disease to remain independent longer, easing the burden on caregivers.



"The main benefit of memantine comes late in the illness and appears to have some impact on the quality of life of the patient as well as the caregiver," observes Samuel Gandy, M.D., Ph.D., Chairman of the Scientific Advisory Board of the Fisher Center for Alzheimer's Research Foundation. However, he cautions that caregivers not raise their expectations too high. "The improvements can be very subtle. Researchers might see definite drug effects when families might not notice any change."



In addition, Dr. Gandy points out that scientists disagree on whether the drug has any benefits against the underlying causes of Alzheimer's itself, including the death of brain cells. "New experimental medicines that target these fundamental changes in the disease are now in clinical trials and hold promise for arresting, preventing, or perhaps even reversing brain degeneration," he says.



Drs. Gandy and Reisberg will be available to answer your questions about this promising new drug and other Alzheimer's concerns at the http://alzheimer-info.blogspot.com/



Alzheimer's Drugs

Memantine is not yet available at U.S. pharmacies. Further review is required before the Food and Drug Administration (FDA) decides whether to approve it for sale. That could take several months to a year, says Dr. Reisberg. Until then, your doctor cannot prescribe it. The drug has recently been approved for treating Alzheimer's in Germany and other European countries, where it sells for about $600 a month.



Further study is needed to determine how long benefits may persist, and whether the pill may work in the early stages of the illness or when combined with existing Alzheimer's drugs. The findings may also be applicable to other degenerative nerve diseases, such as Parkinson's, and possibly even glaucoma, Dr Reisberg says.



The drug works in a new way, shielding brain cells from overexposure to a brain chemical called glutamate. Short bursts of glutamate help to lock in memories. But when levels of the substance become persistently high, as in Alzheimer's disease, brain cells die off. Memantine blocks a receptor for glutamate, shielding brain cells from its damaging effects while allowing the short pulses that foster memory and learning.



Currently available Alzheimer's drugs are aimed at slowing the destruction of acetylcholine and other chemicals in the brain that promote communication between cells. They have limited effectiveness, however, and are generally prescribed for the earlier stages of the illness.



Nearly five million Americans have Alzheimer's disease, with the number growing rapidly. Memantine offers a possible new avenue of treatment for many of these patients, as well as the almost 500,000 new cases diagnosed each year.



Results of the study were published in the April 3, 2003, issue of the esteemed New England Journal of Medicine.