Nov 4, 2009

Dimebon Contact and Constellation -- Pfizer And Medivation Initiate Two Phase 3 Trials

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.”
Subscribe to The Alzheimer's Reading Room--via Email

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.

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.

Locations, etc are not yet available. I will publish them on the Alzheimer's Reading Room as the information becomes available.

Popular articles on the Alzheimer's Reading Room

The Alzheimer's Action Plan: The Experts' Guide to the Best Diagnosis and Treatment for Memory Problems

Bob DeMarco is the editor of the Alzheimer's Reading Room and an Alzheimer's caregiver. The Alzheimer's Reading Room is the number one website on the Internet for news, advice, and insight into Alzheimer's disease. Bob has written more than 950 articles with more than 8,000 links on the Internet. Bob resides in Delray Beach, FL.

Original content Bob DeMarco, Alzheimer's Reading Room