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| Descriptive Information Fields | |||||||||
| Brief Title † | A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease | ||||||||
| Official Title † | A Double Blind, Placebo Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of Eighteen Months Of Treatment With PF 04494700 (TTP488) In Participants With Mild To Moderate Alzheimer's Disease | ||||||||
| Brief Summary | This Phase 2 study is designed to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease. |
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| Detailed Description | |||||||||
| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Examine the safety and tolerability of PF 04494700 relative to placebo. Adverse events, vital signs, physical exam, neuro exam, 12-lead ECG, lab tests (hematology, blood chemistry, urinalysis) and brain magnetic resonance imaging (MRI). [ Time Frame: 18 Month ] [ Designated as safety issue: Yes ] Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment. [ Time Frame: 18 Month ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition [ Time Frame: 18 Month ] [ Designated as safety issue: No ] Evaluate the potential dose response of PF 04494700 [ Time Frame: 18 Month ] [ Designated as safety issue: No ] Evaluate the pharmacokinetics and characterize the pharmacokinetic (PK)/ pharmacodynamic (PD) relationship of PF 04494700 to potential biomarkers and relevant efficacy and safety endpoints [ Time Frame: 18 Month ] [ Designated as safety issue: No ] |
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| Condition † | Alzheimer's Disease | ||||||||
| Intervention † | Drug: PF-04494700 Drug: Placebo |
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| MEDLINE PMIDs | |||||||||
| Links | To obtain contact information for a study center near you, click here.  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 400 | ||||||||
| Start Date † | December 2007 | ||||||||
| Completion Date | March 2011 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00566397 | ||||||||
| Organization ID | B0341002 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Pfizer | ||||||||
| Collaborators †† | Alzheimer's Disease Cooperative Study (ADCS) | ||||||||
| Investigators † |
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| Information Provided By | Pfizer | ||||||||
| Verification Date | October 2008 | ||||||||
| First Received Date † | November 29, 2007 | ||||||||
| Last Updated Date | October 30, 2008 | ||||||||
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