NCT00566397
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- PF-04494700
- Conditions
- Alzheimer's Disease
- Sponsor
- Pfizer
- Enrollment
- 402
- Locations
- 1
- Primary Endpoint
- 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).
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •History or symptoms of autoimmune disorders.
Arms & Interventions
1
Intervention: PF-04494700
2
Intervention: PF-04494700
3
Intervention: Placebo
Outcomes
Primary Outcomes
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 efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment.
Time Frame: 18 Month
Secondary Outcomes
- Evaluate the pharmacokinetics and characterize the pharmacokinetic (PK)/ pharmacodynamic (PD) relationship of PF 04494700 to potential biomarkers and relevant efficacy and safety endpoints(18 Month)
- Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET)(18 Month)
- Evaluate the potential dose response of PF 04494700(18 Month)
Study Sites (1)
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