SAN FRANCISCO — Medivation, Inc. (Nasdaq: MDVN) today announced that patient enrollment was completed on November 30, 2010 in the CONCERT study, a 12-month, Phase 3 clinical trial in patients with mild-to-moderate Alzheimer’s disease (AD) evaluating the potential efficacy of dimebon (latrepirdine*) when added to ongoing treatment with donepezil.

Medivation is conducting this study under its collaboration agreement with Pfizer Inc.

“Completing patient enrollment in CONCERT is an important step forward for our dimebon development program in Alzheimer’s disease,” said Lynn Seely, M.D., chief medical officer of Medivation. “Now that enrollment is complete, we expect to report top-line results from the CONCERT trial in the first half of 2012. We have previously received feedback from the FDA confirming that we can use our Phase 3 CONCERT trial to complete our registration package for mild-to-moderate Alzheimer’s disease, provided that the results are robustly positive.”

The international, randomized, double-blind, placebo-controlled Phase 3 CONCERT trial enrolled 1,003 patients with mild-to-moderate AD at approximately 100 sites in the United States, Australia, New Zealand and Western Europe. Patients on a stable dose of donepezil were randomized to one of three treatment groups: dimebon 20 mg three times per day, dimebon 5 mg three times per day or placebo. Patients were required to be on treatment with donepezil for at least six months and at a stable dose of 10 mg daily for at least four months prior to enrollment in the study. The primary endpoints are the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) – a measure of self-care and daily function.

About Dimebon

Dimebon (latrepirdine*) is an investigational oral medication being tested as a potential treatment for Alzheimer’s disease and Huntington disease. In addition to the CONCERT trial, dimebon is also being tested in the HORIZON trial, a six-month Phase 3 study evaluating dimebon in patients with Huntington disease. Medivation expects to report top-line results from the HORIZON trial in the first half of 2011. For further information on dimebon clinical trials, please visit www.dimebontrials.com or www.clinicaltrials.gov.

About Alzheimer’s Disease

Alzheimer’s disease is a progressive degenerative brain disorder that gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry out daily activities. As the disease progresses, patients may experience changes in personality and behavior, such as delusions, hallucinations, anxiety and agitation.

About the Pfizer/Medivation Dimebon Collaboration

Medivation and Pfizer have a global collaboration to develop and commercialize dimebon for the treatment of Alzheimer’s disease and Huntington disease. For more information about Medivation, visit www.Medivation.com.

*Latrepirdine is the proposed generic (nonproprietary) name for dimebon.

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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.

Dimebon Alzheimer?s Disease

http://www.psychiatry.co.il/

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http://www.dimebonalzheimers.com