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PF-04494700- Low Dose Arm

Phase 2

Alzheimer Disease | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Aug 20, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

PF-04494700- Low Dose Arm · 1 trial · 1 indication

Phase 2 1
NCT00141661A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's PatientsAlzheimer Disease
COMPLETED67 Analytics
PHASE2COMPLETED
A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety Measures include Adverse Events
Every Visit
Laboratory Tests
Every Office Visit
12-Lead Electrocardiogram
Every Office Visit
24-Hour 12-Lead Serial ECGs
Baseline, Study End

Secondary Endpoints

Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta
Baseline, Visit 5, Study End
Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL
Screening Visit, Baseline, Study End
Pharmacokinetic Profile
Baseline and Every Office Visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low Dose ArmEXPERIMENTAL -
High Dose ArmEXPERIMENTAL -
Placebo ControlPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-04494700 - Low Dose ArmDRUG30 mg loading dose for 6 days, followed by 10 mg daily
PF-04494700 - High Dose ArmDRUG60 mg loading dose for 6 days, followed by 20 mg daily
Placebo ComparatorDRUGMatching placebo.
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Diagnosis of probably Alzheimer's disease for at least 1 year. * Mini Mental State Exam (MMSE) score between 12-26 at screening. * Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months. Exc...

Countries:United States
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Frequently asked questions about PF-04494700- Low Dose Arm

What is PF-04494700 used for?

PF-04494700 is an investigational small molecule being studied for Alzheimer's Disease and Diabetic Nephropathy. It has been evaluated in Phase 2 clinical trials for these conditions, including mild to moderate Alzheimer's Disease. The drug is not approved and remains in clinical development.

Who makes PF-04494700?

PF-04494700 is being developed by Pfizer, Inc., which trades under the ticker PFE. The company has conducted Phase 2 clinical trials of the drug for Alzheimer's Disease and Diabetic Nephropathy.

What phase is PF-04494700 in?

PF-04494700 is in Phase 2 clinical development. It has completed Phase 2 trials for Alzheimer's Disease and Diabetic Nephropathy. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PF-04494700 in?

PF-04494700 has completed three Phase 2 trials: NCT00141661, a safety and tolerability study in Alzheimer's patients; NCT00287183, a 6-month study in type 2 diabetes with albuminuria; and NCT00566397, an efficacy and safety study in mild to moderate Alzheimer's Disease.

Is PF-04494700 the same as TTP488?

PF-04494700 is also known as TTP488. In clinical trial NCT00287183, the drug is referred to as TTP488, indicating that these names refer to the same investigational compound being developed by Pfizer.