Study Set To Provide Breakthrough In Treatment Of Alzheimer’s

A ground-breaking clinical trial which could help halt the onset of advanced Alzheimer’s and dramatically improve the quality of life for patients and carers has been launched in the UK.

Glasgow Memory Clinic is now enrolling patients in the CONCERT trial, a one-year international study set up to test the effectiveness of a unique investigation drug, dimebon (also known by its proposed generic name of latrepirdine), in patients currently taking Aricept (donepezil HCI tablets), the leading medication for Alzheimer’s disease worldwide.

More than 1,000 patients from across western Europe, the United States, Australia and New Zealand will take part in the CONCERT trial and it is hoped that the combined medication will help stabilise the condition of those with Alzheimer’s by safely improving cognition (thinking and awareness), memory, daily functioning, behaviour and the ability to care for oneself.

Glasgow Memory Clinic has already enrolled a number of patients onto the trial and still has spaces available for those who meet the eligibility criteria.

Dr Fraser Inglis, Consultant Physician and founder of the Glasgow Memory Clinic, is optimistic about the advances the trial may make in the treatment of Alzheimer’s disease.

“Alzheimer’s is a complex disease and while current medications may improve the symptoms for some patients for a time, often the disease continues to progress. Therefore, combination therapy may be the method to maximize clinical benefit,” said Dr Inglis.

“CONCERT is an important study because dimebon is thought to work differently to current medications and this study will evaluate whether adding it to one of the most commonly used Alzheimer’s medications will provide a more effective symptomatic treatment to patients, stabilising their condition and ultimately improving their quality of life.

“A cure for Alzheimer’s is still many years away, however treatments that provide lasting effects, more symptomatic benefits or slow disease progression would offer meaningful benefits for patients and their carers. For this reason, there is an urgent need for patients to participate in clinical trials such as CONCERT and help advance the understanding of how Alzheimer’s disease can be better treated.”

The Alzheimer’s Society estimates that as many as 417,000 people in the UK are living with  Alzheimer’s, a devastating disease that hinders the patient’s ability to remember, learn, perform daily activities and relate to others. As the baby boomer population ages, the incidence of Alzheimer’s is expected to increase dramatically.

Mrs Balneaves, wife of an Alzheimer’s sufferer adds: “As the wife and carer of an Alzheimer’s patient, I understand fully how debilitating this disease is and how, in the majority of cases, it leaves sufferers requiring round-the-clock care and unable to interact fully with society.

“It causes untold suffering not only to the person with the disease, but also to their family and friends, and I can only welcome any research that can provide renewed hope of an improved quality of life for anyone touched by Alzheimer’s.”

The Glasgow Memory Clinic is based in a new £4m facility within the West of Scotland Science Park and is internationally recognized as a leading independent research organization dedicated to finding better treatments for those with Memory Impairment, Alzheimer’s disease and dementia.

Patients or caregivers interested in participating in the CONCERT trial are invited to contact the Glasgow Memory Clinic for information on eligibility and enrolment on 0141 948 0206 or http://www.glasgowmemoryclinic.com/. Further information is also available on the Concert study freephone number 0808 178 7959 or www.concertstudy.com.

About Concert

Concert (http://www.concertstudy.com/) is an international, randomised, double-blind, placebo-controlled study that will enrol approximately 1,050 patients with mild-to-moderate Alzheimer’s disease at approximately 100 sites in western Europe, the United States, Australia and New Zealand. Patients on a stable dose of Aricept will be randomised to one of three treatment groups: dimebon 20 mg three times per day, dimebon 5 mg three times or placebo.

The primary endpoints are the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS – ADL), a measure of self-care and daily function. The Concert study is sponsored by Pfizer and Medivation, Inc.

About Dimebon

Dimebon (latrepirdine) is an investigational drug currently in Phase 3 development for the treatment of Alzheimer’s disease and in clinical development for Huntington disease (HD). The comprehensive Phase 3 clinical development programme for Alzheimer’s disease is evaluating the potential for dimebon to be used in broad applications including use alone, in combination with existing medications and in patients at all stages of the disease.

Dimebon has a unique mechanism of action, distinct from currently available treatments. In preclinical studies, dimebon has been shown to protect brain cells from damage and enhance brain survival, potentially stabilizing and improving mitochondrial function. Mitochondria are critical to brain cell functioning as they are the primary source of energy for cells. Drugs that protect mitochondria or restore their function could potentially be a valuable treatment approach in AD.

Issued by Beattie Communications (www.beattiegroup.com) on behalf of Glasgow Memory Clinic (http://www.glasgowmemoryclinic.com/)

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Perhaps the most prescribed category of drugs for Alzhimer’s disease are the “Cholinesterase Inhibitor”  branch.  This group and grouping includes four medications.  Their trade names are “Aricept” , “Cognex” , “Excelon”  and “Reminyl”.  This group of medications , specifically the  “Cholinterase Inhibitors”   work via a mechanism of raising brain levels of the chemical neurotransmitter in the brain , acetylcholine , that is deficient in people and patients who exhibit the signs , symptoms and progression of Alzheimer’s Disease and its variants.

It can be said that overall these drugs , and this classification of medications , work to slow the progression of Alzheimer’s Disease.

In terms of side effects , and the range and variations of side effects with the Cholinesterase classification of drugs  side effects are all pretty similar in their type and range.  This generally includes , nausea , vomiting ,diarrhea , stomach pain, and loss of appetite.  However care must be exhibited with the drug / medication Cognex which can work to effect and cause liver toxicity and toxicities.

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Dimebom is a new pharmaceutical treatment alternative for patients suffering from Alzheimer’s Disease.   Dimebon is an older medication that has recently been discovered to be most helpful in treating patients with Alzheimer’s disease.   Dimebom (the actual drug is known chemically as Dimebolin) is an older  Russian antihistamine drug.  It was popularly used in Russia as an antihistamine for hayfever, allergies and the like.  In fact the drug was sold as an easy to obtain antihistamine – sold over the counter without a prescription.

Dimebom is currently in clinical trials in the United States by a company named Medivation .    The website for Medivation, the pharmaceutical company involved with the clinical development and testing of Dimebom in the United States? Can be found at link   www.medivation.com .   To learn more about Medivation’s clinical trials of Dimebom the link is

http://www.medivation.com/pipeline_dimebontrials.html#p3

For more information on CONNECTION study locations, eligibility and enrollment, please visit www.connectionstudy.com or call toll-free 1-877-888-6386

At this point in time Dimebom is not available in any manner to Alzheimer Patients or their families, outside of the study material afforded by the Medivation Company and the Medivation clinical trials themselves.

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Advantages of Razadyne ( galantamine) include that it may not as much disturb sleep and the sleep process in Alzheimer’s patients as the other mainstay medication of treatment of Alzheimer’s Aricept.

Common side effects of Razadyne include possible nausea , vomiting ,diarrhea ,fainting , loss of appetite and weight loss.? Most of these are mild and tend to subside as the body learns to adjust to the medication over time.

In M.C.I. trials Razadyne , thirteen ( 13) Razadyne recipients died, compared to only a single ( one) death among placebo patients – a finding that it seems of not many doctors are aware of.? Because more deaths occurred in the Razadyne group , than in the placebo group, doctors cannot rule out that the deaths were somehow related or due to Razadyne therapy.

Razadyne therapy can be initiated for patients with mild or moderate Alzheimer’s disease.

Dosage:? Razadyne? is supplied in both regular and extended release forms. Razadyne ER ( or SR designation slow- release formulation), can be taken once a day whereas Razadyne immediate release formulations are taken on a twice a da regime.? The two different formulations of Razadyne – immediate release and slow extended or sustained release formulations should not be taken together at the same time.? Its either one or the other since the active medication ingredient is the same.

The effective dose of Razadyne Extended Release (ER)? as well as immediate release ( regular) Razadyne? is stated to be in the ranges of 16 to 24 milligrams a day.? Doctors usually recommend starting with a lower initial dose of 8 milligrams a day and then increasing it to the lower maintenance dosage of 16 mg over a time span period of four ( 4) weeks. Then up according to the specific patients requirements and needs over a time span the dosage can be increased to upper stated limits of the drug.? Often patients can tolerate medications at higher levels if first started on a much lower initial dose and the dosage increased slowly over time.? The maxim is start lower and increase dosage slowly over time.

To reduce side effects , in terms of sleep disturbances and insomnia it is especially recommended to take the medication in the morning time with the extended release ER / SR form , and the taking of the second dose of the immediate release form somewhat earlier during the 24 clock of the daytime rather than later.

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The medication? Razadyne was originally made from daffodil flowers using the very same extract that soldiers in ancient Greece used to stay alert on the battlefields.?? The drugs commercially available of Razadyne currently use a synthetic version or variant of this initial compound.

Radazyne not only blocks cholinesterase in the same way that the Alzheimer’s drug Aricept does but also and in addition stimulates the brain’s? nicotine and nicotinic receptors.? The nicotinic receptors in the brain serves the brain functioning and are involved in attention and learning facilities and functions and functioning.

Originally researchers had hoped that this double pharmacological actions would serve to double the drug’s benefits in treatment as well.

However clinical trials of Rasadyne ( chemically or generically galantamine) have not borne this out as well.

As a general guideline and measure Razadyne is generally held to be as effective in the ranges as that of Aricept.

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What are the result of data on followup studies of patient’s taking and prescribed the aricept medication for the treatment of Alzheimer’s disease ?

Several studies ( some lasting as long as five (5) years)?? have ascertained and concluded that these patients declined and had their Alzheimer’s disease and cognitive symptoms declined at a slower rate than would of been expected? otherwise without therapy??? However these studies could be criticized as not being that well standardized or with a small patient count and being of short duration.

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Aricept was approved by the FDA for treating severe Alzheimer’s patients making it one of the few drugs indicated for all three stages of Alzheimer’s disease

Three preliminary studies have indicated and reported that patients who take Aricept have slightly less Alzheimer’s related loss in brain volume and volumes than those not being prescribed and taking the medication

A major three year study by the National Institutes of Health found that Aricept helped delay dementia for about eighteen months in patients with MCI.? At thirty six months, only a small subset of participants maintained these benefits. those with APOE4 gene , which increases a person’s risks of developing Alzheimer’s.

Aricept is one of the few CHeI studied exclusively in elderly African Americans with Alzheimer’s who had a similar response to others.? But because ethnic groups metabolize some drugs differently scientists view drugs in diverse ethnic groups more favorably.? At present most of the FDA approved meditations have been studied in Asians as well as Latin American ethnic groups.

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The question is often asked as to what is the “best ” dosage when it comes to the medication? Arciept.?? As with all medications there is no one “best ” dosage.? Dosages vary tremendously depending on the patient , their stage of the disease , what other medications they are taking currently and concurrently as well as a host of other factors.? Including in this equation is how much and for how long can the patient tolerate the drug to begin with.

What can be said easily? is what is the initial dosage and what are the “standard”? or usual dosages.

In the case of Aricept ten mg ( milligrams or thousandth’s of a gram) usually can be said to provide the most consistent benefits and is the usual standard optimal amount.

Doctors and Alzheimer’s patients medical teams ( under the direction and supervision of the captain of the team the physician), usually initiate Aricept treatments at a somewhat lower starting dose of 5 mg? once daily.

Then after a sutiable time period , usually in the ranges of four to six weeks increase the dose to that level of 10 milligrams.

Both fice (5) milligrams and 10 mg daily are effective, and thus people and patients who cannot tolerate 10 milligrams may tolerate 5 mg and thus remain on a dose that they can both tolerate and that they can ultimately benefit from.? In some of these cases , after a somewhat longer or even lengthy time period , the patient may go on to be able to tolerate the higher ten mg a day doseage and benefit from this level as well.

It should be noted that in very frail people or those with major concerns about side effects, the Aricept dosage can be started at an even lower dosage than the 5 mg a day , by providing for administration of the Aricept medication on alternate days.? Usually taken with dinner or breakfast ( to tie in with a daily habit in order to increase medication compliance by the patient).? As well as tablet forms Aricept is also available as an orally Disintegrating tablet format .? This dissolves in the mouth and does not need to be directly or mechanially swallowed.? Many patients do have problems when it comes to swallowing pills and tablet intact.

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Common Side Effects of Aricept ( generically known as doneperzil) , include possible nausea, vomiting , diarrhea, bruising, fainting , insomnia or “not sleeping well”, loss of appetite, feeling tired and finally possibility of muscle cramps and cramping.

Most of these side effects could be said to mild and tend or tended to subsidize as the body adjusts to the medication over a number of days or extended time period .? Aricept may be more likely than Exelon or Razadyne to cause mild sleep problems such as vivid dreams as well as possible nocturnal illusions.? Urinary problems? are often occasionally seen with the use of Aricept.

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