A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.

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

Details

• Lead Sponsor: Pfizer
• Collaborator: Medivation, Inc.

Criteria

Inclusion Criteria:

• Are men and women ≥ 50 years of age with a diagnosis of Alzheimers disease.

• Have a Mini-Mental State Exam between 5 and 14 inclusive.

• Have been taking the medication memantine (ie., Namenda) for at least six months prior to this study.

• Must have a caregiver who assists the patient at least five days per week for at least three hours per day, who can accompany patient to study visits, and who has an intimate knowledge of the patient's health states and personal care.

Exclusion Criteria:

• Have taken medicines for Alzheimers disease other than memantine (e.g., donepezil, rivastigmine, galantamine, tacrine) within 2 months prior to this study.

• Dementia other than Alzheimers disease.

• Any medical condition or reason that interferes with the ability of the patient to participate in or complete the trial or places the patient at undue risk, as judged by the study doctor.