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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medivation, Inc.

Criteria

Inclusion Criteria:

• Mild-to-Moderate Alzheimer's disease

• Probable AD (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)

• MMSE score 10-24 inclusive

• Computerized tomography (CT) san or magnetic resonance imaging (MRI) consistent with AD

• Caregiver who cares for the patient at least 5 days per week

Exclusion Criteria:

• Anti-dementia drugs including cholinesterase-inhibitors or N-methyl-D-aspartate receptor (NMDA) receptor antagonists within 90 days

• Other causes of dementia

• Other primary psychiatric or neurological disorders

• Unstable medical illnesses or significant hepatic or renal disease