| June 1, 2009 |
| March 3, 2010 |
| September 2009 |
| October 2011 (final data collection date for primary outcome measure) |
- Change from baseline in the Severe Impairment Battery [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- Change from Baseline in ADCS-Activities of Daily Living (severe) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
|
| Same as current |
| Complete list of historical versions of study NCT00912288 on ClinicalTrials.gov Archive Site |
- Change from baseline in the Neuropsychiatric Inventory [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- Change from baseline in the Clinician's Global Impression of Change (plus caregiver input) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Mini-mental State Exam [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- Change from baseline Resource Utilization in Dementia [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- Change from baseline in EuroQoL - 5 Domain assessment [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- Safety and Tolerability including adverse events and summary of clinically important changes in clinical safety laboratory assessments, electrocardiograms, and vital signs [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease |
| A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 26-Week Trial To Evaluate The Efficacy And Safety Of Dimebon In Patients With Moderate-To-Severe Alzheimer's Disease |
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 III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Alzheimer Disease |
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| |
| |
| Recruiting |
| 576 |
| November 2011 |
| October 2011 (final data collection date for primary outcome measure) |
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.
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| Both |
| 50 Years and older |
| No |
| Contact: Pfizer CT.gov Call Center |
1-800-718-1021 |
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| United States, Canada, Germany, Portugal, Slovakia, Spain, Turkey |
| |
| NCT00912288 |
| Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| B1451006 |
| Pfizer |
| Medivation, Inc. |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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|
| Pfizer |
| March 2010 |