Status:
COMPLETED
A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease
Lead Sponsor:
Medivation, Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
598 Patients enrolled
Trial Details
Trial ID
NCT00675623
Start Date
May 1 2008
Last Update
September 27 2016
Active Locations (28)
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1
Phoenix, Arizona, United States, 85004
2
Costa Mesa, California, United States
3
Fresno, California, United States, 93720
4
Rancho Mirage, California, United States