Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
NCT00829374 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1003
Last updated 2016-09-27
Summary
The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.
Conditions
Interventions
- DRUG
-
Dimebon
5 mg orally three times daily
- DRUG
-
Dimebon
20 mg orally three times daily
- DRUG
-
Placebo comparator
Placebo orally three times daily
Sponsors & Collaborators
- collaborator INDUSTRY
-
Medivation, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2011-12-31
- Completion
- 2011-12-31
Countries
- United States
- Australia
- Belgium
- Finland
- France
- Germany
- Italy
- New Zealand
- Sweden
- United Kingdom
Study Locations
More Related Trials
-
An Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon In Patients With Alzheimer's Disease
NCT00939783 ·Status: TERMINATED ·Phase: PHASE3
-
An Extension of the CONCERT Protocol (DIM18)
NCT01152216 ·Status: TERMINATED ·Phase: PHASE3
-
A Brief Study To Evaluate The Safety, Tolerability, And Blood Levels Of Multiple Doses Of PF-044467943 Or Placebo In Combination With Donepezil In Subjects With Mild To Moderate Alzheimer's Disease
NCT00988598 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects
NCT00825084 ·Status: COMPLETED ·Phase: PHASE1
-
Double-blind, Placebo-controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease
NCT00377715 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF 01913539) On The Single-Dose Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects
NCT00827034 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease
NCT00704782 ·Status: TERMINATED ·Phase: PHASE2
-
The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
NCT00293176 ·Status: COMPLETED ·Phase: PHASE4
-
The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil
NCT01024660 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
A Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF 01913539] In Subjects With Severely-Impaired And Normal Renal Function
NCT00824590 ·Status: COMPLETED ·Phase: PHASE1
-
Donepezil to Treat Dementia in Parkinson's Disease
NCT00030979 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
NCT01266525 ·Status: COMPLETED ·Phase: PHASE2
-
Placebo-Controlled Crossover Study to Evaluate Donepezil and MK-3134 for Reversal of Cognitive Impairment Associated With Scopolamine Administration (3134-005)(COMPLETED)
NCT01181310 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease
NCT01066481 ·Status: WITHDRAWN ·Phase: PHASE2
-
An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease
NCT01066546 ·Status: TERMINATED ·Phase: PHASE3
-
Acute Effects Of Donepezil On Brain Perfusion And Memory In Subjects With Cognitive Impairment And Mild Alzheimer's Disease
NCT01082965 ·Status: TERMINATED ·Phase: NA
-
Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease
NCT00708552 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease
NCT02787746 ·Status: COMPLETED ·Phase: PHASE4
-
The Effectiveness And Safety Of Donepezil Hydrochloride (E2020) In Subjects With Mild To Severe Alzheimer's Disease Residing In An Assisted Living Facility
NCT00571064 ·Status: COMPLETED ·Phase: PHASE4
-
A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
NCT00930059 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).
NCT02695004 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate DNL747 in Subjects With Alzheimer's Disease
NCT03757325 ·Status: COMPLETED ·Phase: PHASE1
-
Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease
NCT02322021 ·Status: TERMINATED ·Phase: PHASE2
-
Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)
NCT01600859 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)
NCT03114657 ·Status: TERMINATED ·Phase: PHASE3