A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT00566397|
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : November 30, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: PF-04494700 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||402 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
15 mg for 6 days followed by daily dosing of 5mg
60 mg for 6 days followed by daily dosing of 20mg. Dosing in this arm has been discontinued.
|Placebo Comparator: 3||
- 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 ]
- 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 ]
- Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET) [ Time Frame: 18 Month ]
- Evaluate the potential dose response of PF 04494700 [ Time Frame: 18 Month ]
- 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 ]
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|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening.
- Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization
- Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia.
- Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations.
- Evidence or history of diabetes mellitus Type 1 or Type 2.
- History or symptoms of autoimmune disorders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566397
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
|Other Study ID Numbers:||
|First Posted:||December 3, 2007 Key Record Dates|
|Last Update Posted:||November 30, 2018|
|Last Verified:||November 2018|
RI RI Study Rage Inhibitors
Central Nervous System Diseases
Nervous System Diseases