A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease (CONNECTION)
The Connection Study is a six-month confirmatory Phase 3 study to determine the safety and efficacy of Dimebon in the treatment of mild-to-moderate Alzheimer's disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease (CONNECTION)|
- To determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the ADAS-cog; and to determine the effect of Dimebon as compared to placebo on the primary measure of global function, the CIBIC-plus. [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
- To determine the effect of Dimebon as compared to placebo on a measure of self care and daily function, the ADCS-ADL; • To determine the effect of Dimebon as compared to placebo on a measure of behavior, the NPI; [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Dimebon, 5 mg orally three times daily
Dimebon, 5 mg orally three times daily for six months
Dimebon 20 mg orally three times daily
Dimebon 20 mg orally three times daily for six months
Placebo Comparator: C
Placebo orally three times daily for six months
Placebo three times daily for six months
This study is a randomized, placebo-controlled 6-month study designed as an adequate and well-controlled trial to demonstrate the safety and efficacy of Dimebon in the treatment of patients with mild-to-moderate AD. Dimebon is an investigational drug for Alzheimer's disease. The target of Dimebon's mechanism of action are the mitochondria (a cell's primary source of energy).The Connection Study is the second of two pivotal studies evaluating the effect of Dimebon. It is a 6-month study enrolling 525 patients in the United States, Europe, and South America. All patients completing the 6-month study will be eligible to receive Dimebon in an open-label extension trial.
The patient population will be carefully selected to ensure inclusion of patients with AD, rather than other types of dementia. Mild-to-moderate disease will be defined by the screening MMSE. Patients will attend study visits with caregivers who will provide information about the patient's condition.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675623
Show 28 Study Locations
|Study Director:||Lynn Seely, MD||Medivation, Inc.|