NCT00675623

A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 598 (actual)
• Sponsor: Medivation, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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 (AD).

Detailed description

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 Mini-Mental State Examination (MMSE). Patients will attend study visits with caregivers who will provide information about the patient's condition.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Dimebon	Dimebon, 5 mg orally three times daily for six months
DRUG	Dimebon	Dimebon 20 mg orally three times daily for six months
DRUG	Placebo	Placebo three times daily for six months

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-12-01
• First posted: 2008-05-09
• Last updated: 2016-09-27

Locations

28 sites across 1 country: United States