Pfizer Inc (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) announced results from the Phase 3 HORIZON trial of the investigational drug dimebon (latrepirdine*) in patients with Huntington disease. Dimebon did not achieve statistical significance for either of the co-primary endpoints, the Mini-Mental State Examination (MMSE)which measures cognition (p=0.39), or the Clinician’s Interview-Based Impression of Change, plus caregiver input (CIBIC-plus), which measures global function (p=0.84).

“We are disappointed with the results of the HORIZON trial given the high unmet need in this patient population. At this point, we will discontinue development of dimebon in Huntington disease, including the ongoing open-label extension study,” said David Hung, M.D., president and chief executive officer of Medivation. “We will continue our ongoing 12-month Phase 3 CONCERT trial of dimebon and its open-label extension in patients with mild-to-moderate Alzheimer’s disease. We expect to report top-line data from CONCERT in the first half of 2012.”

Dimebon was generally well tolerated in the HORIZON trial, consistent with findings from previous trials including over 2,000 patients, the large majority of whom were Alzheimer’s disease patients.

“Huntington’s is a challenging disease area, and we are also disappointed with the HORIZON results,” said Pfizer’s Steve Romano, M.D., senior vice president, Medicines Development Group head, Primary Care Business Unit. “The results are expected to be presented at an upcoming medical meeting.”

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

HORIZON Study Design and Results
The double-blind, placebo-controlled Phase 3 HORIZON trial enrolled 403 patients with Huntington disease at 64 sites in North America, Europe and Australia. The trial included patients who had cognitive impairment, based on investigator judgment and verified by MMSE score. Patients were randomized to receive either 20 mg of dimebon three times daily or placebo for six months.

No statistically significant improvements were achieved for the dimebon group relative to placebo on either of the co-primary endpoints. Dimebon was generally well tolerated in the study. The overall incidence of adverse events was equivalent between the treatment groups: 69 percent in the dimebon group and 68 percent in the placebo group. Adverse events occurring in at least 5 percent of dimebon treated patients and more frequently than in placebo treated patients were chorea (8 percent vs. 4 percent), headache (6 percent vs 3 percent) and fatigue (5 percent vs 0 percent).

The trial was conducted in collaboration with the Huntington Study Group (HSG) and the European Huntington’s Disease Network (EHDN). The HSG is a non-profit group of experienced clinical trial investigators from medical centers in the United States and abroad dedicated to clinical research of Huntington disease. The EHDN is a non-profit network of professionals providing an infrastructure for large scale Huntington disease clinical trials throughout Europe.

About Dimebon
Dimebon (latrepirdine) is an investigational oral medication being tested as a potential treatment for Alzheimer’s disease. Dimebon is currently being studied in the Phase 3 CONCERT trial, a 12-month study evaluating dimebon in patients with mild-to-moderate Alzheimer’s disease who are taking donepezil, a commonly prescribed Alzheimer’s disease medication.

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. Under the terms of the agreement, the companies work together on the dimebon development program.

http://www.worldpharmanews.com/pfizer/1641-pfizer-and-medivation-announce-results-from-phase-3-horizon-trial-of-dimebon-in-huntington-disease

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Dimebon

Dimebon (latrepirdine), a pill being developed for Alzheimer’s disease, has been found to improve mental abilities in some patients with Huntington’s disease, says a new study.

The research has been published in the Archives of Neurology.

“This is the first clinical trial that has focused on what is perhaps the most disabling aspect of the disease,” said University of Rochester Medical Center neurologist Karl Kieburtz, M.D., the lead author of the study. “While more investigation needs to be done, these results are encouraging and show, for the first time, a statistically significant benefit in terms of improved cognitive function in patients with Huntington’s disease.”

Huntington’s disease is a progressive neurodegenerative disorder that impacts movement, behavior, cognition, and generally results in death within 20 years of the disease’s onset. The disease steadily erodes a person’s memory and their ability to think and learn. Over time, this cognitive impairment contributes to the loss of the ability to work and perform the activities of daily life. There are no treatments current available that effectively alter the course of the disease or improve cognition.

It is believed that mitochondria – the part of the cell that helps convert food to energy – plays a role in the development of Huntington’s disease. Lampridine stabilizes and enhances mitochondrial function, a result that has been shown to improve behavioral, cognitive, and functional outcomes in Alzheimer’s disease. Scientists speculate that this may have the same effect in patients with Huntington’s disease.

The investigators studied the impact of the drug on 91 patients over a 90 day period.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

The cholinteresterase inhibitors thus far available  are currently only approved by the F.D.A. (The US Food and Drug Administration)  , are approved by the FDA as only being effective for Alzherimer patients who have thus far mild to moderate disease.  However these drugs and medications – that is the cholinesterase classification medication grouping, may well show promise for those who are in the earliest as well as later stages of the disease , as well.  In addition they could well be of benefit and benefits to those with mil cognitive impairment as well.

One large study evaluated the use of Aricept (dozepezil) in the treatment of mild cognitive  impairment and found that it significantly reduced conversion to active Alzheimer’s progressive disease.

Current Treatment for Alzheimer’s Disease – Prescription cholinesterase inhibitors include Exelon and Aricept. These drugs have varying side effects and can have contraindications with other medication, so it can be difficult for doctors to find the right pharmaceutical match and …

Methods and compositions using cholinesterase inhibitors – The invention provides methods for treating and/or preventing Alzheimer’s disease, psychiatric illnesses, encephalitis, meningitis, fetal alcohol syndrome, Karsakoff’s syndrome, anoxic brain injury, cardiopulmonary resuscitation …

alzheimer disease – These drugs are called cholinesterase inhibitors because they inhibit the enzymes that break down acetylcholine (acetylcholinesterase and butyrylcholinesterase). Some drugs target only acetylcholinesterase, whereas some target both …

Galantamine: Welsh daffodils containing galantamine may help fight … – Galantamine is a competitive and reversible cholinesterase inhibitor. It is believed it works by enhancing cholinergic function by increasing the concentration of acetylcholine in the brain. The atomics resolution 3D structure of the …

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While cholinesterase inhibitors are now believed to he most helpful in persons with severe Alzheimer’s disease ,sometimes patients can be maintained on these classes and classifications of drugs indefinitely due to the fact and observation that in clinical practice , that often patients who stop taking these drugs or types of medications deteriorate rapidly when the drugs are arbitrarily stopped or withdrawn.  Indeed there is new and upcoming evidence from studies that suggest that stopping cholinesterase inhibitors will result in decline in functioning to a level that the patient would have been at it they – he or she – had not been taking the drug in the first place.

In addition drugs in this class appear to have an added benefit in improving behaviour as well as overall cognitive abilities.

Dimebon Alzheimer?s Disease

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Currently in 2009 , there are several classes and broad classifications of drugs , medications and supplements on the “market”  on in the wares of practitioners – and “alternative”  therapy practitioners as well as support staff and systems in the medical and health care communities.  These can be used and utilized to treat and better control the cognitive symptoms of Alzheimer’s.

Exclusive Interview With Alzheimer’s Expert – Thies: The most mature theory of Alzheimer’s is the so-called amyloid hypothesis. And we should emphasize that this still is a hypothesis. Until we can show that if we change the amyloid concentration in the brain and it changes the course … Thies: The way that they measure the impact of Alzheimer’s drugs is on cognitive measures. There are multiple scales for measuring the course of the disease. We can measure people’s memory, we can measure other kinds of functional …

Natural health blog for healthy living – The similarities between Alzheimer’s disease and dementia with Lewy bodies can make diagnosis difficult. Symptoms such as cognitive decline, memory loss, language difficulties, mood changes, and disorientation are characteristic of both …

Natural Remedies Blog » Blog Archive » Study Shows Ways to Improve … – There was no relationship between higher fitness levels and brain changes in the group of people without dementia. “People with early Alzheimer’s disease may be able to preserve their brain function for a longer period of time by exercising regularly and potentially reducing the amount … Evidence shows decreasing brain volume is tied to poorer cognitive performance, so preserving more brain volume may translate into better cognitive performance,” according to Dr. Burns …

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Dimebon Alzheimers Disease

http://www.dimebonalzheimers.com