This is a 6-month study in mild-to-moderate AD to confirm the positive results of the first phase-3 monotherapy study in the same population. MDVN and PFE are also running a 12-month phase-3 study of Aricept ± Dimebon in mild-to-moderate AD (#msg-37046270) and a phase-3 monotherapy safety study in the same population.
Two phase-3 studies in moderate-to-severe AD are planned to begin in 2H09.
The companies have guided for an NDA submission in 2011.
[These new trials are in moderate-to-severe AD; the previously started phase-3 trials, including monotherapy and combination use with Aricept, are in mild-to-moderate AD. The companies have guided for an NDA submission in 2011.]
›International Studies to Evaluate Effects of Dimebon in Combination Therapy: One in Patients on Background Donepezil, One in Patients on Background Memantine
Source: Pfizer Inc 8:00 am EST, Tuesday November 3, 2009
NEW YORK & SAN FRANCISCO--(BUSINESS WIRE)--Pfizer Inc (NYSE: PFE ) and Medivation, Inc. (NASDAQ: MDVN ) today announced the initiation of CONTACT and CONSTELLATION, two Phase 3 trials of the investigational drug dimebon (latrepirdine)* in patients with moderate-to-severe Alzheimer’s disease (AD).
The CONTACT study will assess as primary endpoints the potential benefits of adding dimebon to ongoing treatment with donepezil HCI tablets, the leading AD medication worldwide, on neuropsychiatric symptoms and activities of daily living. The CONSTELLATION study will evaluate as primary endpoints the effects of adding dimebon to memantine HCI, another standard of care, on cognition, memory and activities of daily living.
“Alzheimer’s disease is a growing global epidemic with an unmet clinical need. Many patients with moderate-to-severe Alzheimer’s disease experience behavioral and neuropsychiatric symptoms, which are among the leading causes of placement in care facilities for these patients,” said Pierre N. Tariot, MD, director of the Memory Disorders Center at the Banner Alzheimer’s Institute and study investigator. “These studies are intended to evaluate the potential added benefits of dimebon in combination with current standards of Alzheimer’s care.”
In preclinical studies, dimebon has been shown to protect brain cells from damage and enhance brain cell survival, potentially by stabilizing and improving mitochondrial function. The dimebon mechanism is distinct from currently available AD medications.
“Pfizer and Medivation are committed to developing dimebon as a treatment that may meaningfully improve the lives of patients across the full spectrum of Alzheimer’s disease severity,” said Lynn Seely, M.D., chief medical officer for Medivation. “The initiation of the CONTACT and CONSTELLATION studies is an important milestone in the broad clinical development of dimebon.”
These studies are part of a comprehensive Phase 3 clinical development program, currently consisting of seven trials, to assess the safety and efficacy of dimebon across all stages of Alzheimer’s disease, as monotherapy and in combination with currently available Alzheimer’s treatments, and in Huntington disease.
*Latrepirdine is the proposed generic (nonproprietary) name for dimebon.
About the CONTACT Study
This Phase 3 randomized, double-blind, placebo-controlled study will enroll approximately 600 patients with moderate-to-severe AD and neuropsychiatric symptoms at approximately 75 sites in Europe and South America. Patients who are already taking donepezil will be randomized to also receive either dimebon 20 mg three times daily or placebo for six months.
The CONTACT study is designed to assess patients’ behavioral difficulties and their ability to perform routine activities of daily living. Behavior will be measured by the Neuropsychiatric Inventory (NPI), while self-care and daily function will be measured by the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (severe) (ADCS-ADLsev). Secondary endpoints include measures of cognition, memory, global function, pharmacoeconomic impact, quality of life and safety and tolerability.
For more information about the CONTACT study, please visit www.ContactStudy.com or email contactstudy@medivation.com.
About the CONSTELLATION Study
This Phase 3 randomized, double-blind, placebo-controlled study will enroll approximately 570 patients with moderate-to-severe AD at approximately 80 sites in the United States, Canada and Europe. Patients already taking memantine will be randomized to also receive either dimebon 20 mg three times daily or placebo for six months.
The CONSTELLATION study will evaluate the potential benefits of adding dimebon to ongoing memantine therapy on cognition, memory and activities of daily living. Cognition and memory will be measured by the Severe Impairment Battery (SIB), while self-care and daily function will be measured by the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (severe) (ADCS-ADLsev). Secondary endpoints include measures of cognitive and behavioral symptoms, global function, resource utilization, quality of life, safety and tolerability.
For more information about the CONSTELLATION study, please visit www.ConstellationStudy.com or call 1-877-377-4476.
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 are working in partnership to advance the Phase 3 development program with the goal of submitting a new drug application to the FDA and bringing dimebon to market in the United States. In addition, pending FDA approval, Medivation will co-promote dimebon to specialty physicians in the U.S. Pfizer has responsibility for development, regulatory and commercialization outside of the U.S.‹
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