Dimebon Over Counter Treatment Alzheimer Alzheimer's

Statins and cholesterol serum level controlling drugs have almost become an industry in themselves.  Almost every adult now is on some kind of statin drug.  Yet to a great extent it is a crapshoot for which we will not know the answer as to the health benefits of   lowering serum cholesterol in such a wide spread manner for several generations .  Does lowering serum cholesterol by itself lower the chances of atherosclerosis and heart disease ?  Is it too simple a correlation in itself.  Indeed the narrowing of the arteries in our bodies and circulatory system may be a lot more complex than this very simple assumption.  On top of that there are , and must be , other modalities and mechanisms by which the arteries narrow over time and even become occluded than simply cholesterol deposits in the walls of the arteries leading to small and  narrower lumen s.  It is  true that in many cases of Alzheimer’s if blood flow to the brain itself and regions of the brain could be well maintained then to some degree the of Alzheimer’s disease and its progression could be slowed or even reversed.

On the other side of the equation cholesterol play more than a simple and central role in cell growth, repair and regeneration so these factors will be have to be considered in the overall schema as well.

One report concerning Alzheimer’s Disease and the questions of statins :

Eli Lilly and Company (NYSE LLY) announced it will begin enrolling patients this month in two separate but identical Phase III clinical trials of solanezumab(i), previously referred to as LY2062430, an antiamyloid beta monoclonal antibody being investigated as a potential treatment to delay the progression of mild to moderate Alzheimers disease. The trials, called EXPEDITION and EXPEDITION 2, will each include a treatment period that lasts 18 months and are expected to enroll a total of 2,000 patients age 55 and over from 16 countries.

In 2008, Lilly began enrolling patients in two Phase III clinical trials called IDENTITY and IDENTITY 2 for a different potential treatment for Alzheimers disease, a gammasecretase inhibitor that also affects amyloid beta, which is believed to be one of the underlying pathologies of the disease. Patients or caregivers interested in learning how to enroll in either EXPEDITION trial or the IDENTITY trials should visit clinicaltrials.gov or call +1877CTLilly (+18772854559). In combination, the EXPEDITION and IDENTITY trials will include approximately 4,600 patients with Alzheimers disease in over 30 countries around the world.

EXPEDITION and EXPEDITION 2 EXPanding AlzhEimers Disease InvestigaTIONs

The EXPEDITION clinical trials are identical multicenter, randomized, doubleblind, placebocontrolled trials. Patients enrolled in the trials will be randomized in a 11 ratio (500 patients in each trial arm) to receive intravenous infusions of either placebo or 400 mg of solanezumab once every four weeks. Patients who are taking currently available symptomatic treatments for Alzheimers disease can continue treatment during their participation in the EXPEDITION trials. The primary objective of both trials is to test whether solanezumab will slow the cognitive and functional decline of Alzheimers disease patients as compared with placebo. These outcomes will be analyzed using measures of the Alzheimers Disease Assessment ScaleCognitive subscore (ADASCOG(11)), which measures cognitive function with an emphasis on memory, and the Alzheimers Disease Cooperative Study Activities of Daily Living scale (ADCSADL), which measures the ability to independently perform daily activities such as eating, bathing, and using the telephone. Secondary objectives of the trials include different clinical benefits as measured by several brainscanning and biochemical biomarkers and ratings scales, and quality of life impact.

“Current therapies available to treat Alzheimers disease may help with symptoms, but they havent been proven to change the disease progression,” said Eric Siemers M.D., Medical Director, Alzheimers disease research for Eli Lilly and Company. “Biomarker results from a Phase II solanezumab trial give us hope that Lilly is on a path toward a treatment that may slow the rate of progression of Alzheimers disease.”

EXPEDITION will be conducted in Argentina, Brazil, Canada, Japan, and United States. EXPEDITION 2 will be conducted in Australia, France, Germany, Italy, Japan, Korea, Poland, Russia, Spain, Sweden, Taiwan, United Kingdom, and United States.

About Alzheimers Disease

Alzheimers disease is a progressive neurodegenerative condition that is the most common cause of dementia, accounting for 60 to 80 percent of cases(ii). Estimates show that 68 percent of people over age 65 are affected by Alzheimers disease(iii), totaling approximately 5.3 million people in the United States alone(ii). Every 70 seconds, an American is developing Alzheimers disease(ii), and it is the sixthleading cause of death in the United States(ii). The direct and indirect health care costs associated with Alzheimers disease and other dementias in the U.S. are estimated to be about US$150 billion(ii). In 2005, the total cost worldwide of dementia, of which Alzheimers disease is the most common cause, was estimated at US$315.4 billion(iv). The burden to caregivers and health care costs can increase dramatically in the late stages of Alzheimers disease, when patients cannot maintain independent function and are frequently bedridden(ii).

About Solanezumab

Alzheimers disease theory suggests that amyloid beta clumps together and eventually kills brain cells. Solanezumab binds specifically to soluble amyloid beta and thereby may draw the peptide away from the brain through the blood. In shortterm clinical studies, solanezumab appeared to have dosedependent effects on amyloid beta in blood and cerebrospinal fluid. The clinical studies to date have been too short to evaluate any potential delay in the progress of Alzheimers disease. To date, the only side effect experienced in clinical studies that appeared to be associated with solanezumab treatment has been mild chills consistent with an infusion reaction; other side effects reported in the Phase II study include nausea, vomiting, headache, back pain, and cough. For a more complete listing of potential side effects, prospective clinical trial participants should refer to the informed consent document.

i. USAN (United States Adoptive Name council) adopted, INN (International Nonproprietary Name) pending

ii. “2009 Alzheimers Disease Facts and Figures.” Alzheimers Association. Available here. May 13, 2009.

iii. Small, GW, Rabins, PV, Barry, PP, Buckholtz, NS, DeKosky, ST, Ferris, SH, Finkel, SI, Gwyther, LP, Khachaturian, ZS, Lebowitz, BD, McRae, TD, Morris, JC, Oakley, F, Schneider, LS, Streim, JE, Sunderland, T, Teri, LA, Tune, LE. Diagnosis and Treatment of Alzheimers Disease and Related Disorders Consensus Statement of the American Association for Geriatric Psychiatry, the Alzheimers Association, and the American Geriatrics Society. JAMA 1997; 278 13631371.

iv. Wimo A., Winblad B., Jonsson L. An estimate of the total worldwide societal costs of dementia in 2005 (2007) Alzheimers and Dementia, 3 (2), pp. 8191

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