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PF-04494700- Low Dose Arm

Phase 2

Alzheimer Disease | Small molecule | Neurology |Pfizer, Inc.|Trials Updated: Nov 30, 2018

PF-04494700- Low Dose Arm target and mechanism

ModalitySmall molecule

Also known as PF-04494700 (TTP488), PF-04494700

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment579

FDA Designations

No designations recorded

PF-04494700- Low Dose Arm clinical trials

PF-04494700- Low Dose Arm · 3 trials · 3 indications

Phase 2 3
NCT00566397A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED402 Analytics
NCT002871836-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent AlbuminuriaDiabetic Nephropathy
COMPLETED110 Analytics
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 Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics
PHASE2COMPLETED
6-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent Albuminuria
Diabetic NephropathyUnlock trial 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

Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment.
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).
18 Month
Primary endpoint of efficacy will be assessed by comparing the treatment groups based on the change in urinary albumin-creatinine ratio (UACR)
from baseline to end of treatment (Month 6).
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

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
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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
PF-04494700 (TTP488)ACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Low Dose ArmEXPERIMENTAL -
High Dose ArmEXPERIMENTAL -
Placebo ControlPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-04494700DRUG15 mg for 6 days followed by daily dosing of 5mg
PlaceboDRUGPlacebo
PF-04494700 (TTP488)DRUG60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication
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 Sites62

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, psych...

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

What is PF-04494700- Low Dose Arm?

PF-04494700- Low Dose Arm refers to the low-dose treatment group of PF-04494700, an investigational small molecule developed by Pfizer, Inc. (ticker: PFE). It was studied in Phase 2 clinical trials for Alzheimer's disease and diabetic nephropathy. The low-dose arm specifically evaluates a reduced dosage regimen of the drug.

What is PF-04494700- Low Dose Arm used for?

PF-04494700- Low Dose Arm was studied for the treatment of mild to moderate Alzheimer's disease and diabetic nephropathy. These are the two indications explored in its clinical development program. The drug remains investigational and is not approved for any use.

Who makes PF-04494700- Low Dose Arm?

Pfizer, Inc. (ticker: PFE) is the developer of PF-04494700- Low Dose Arm. Pfizer sponsored the Phase 2 clinical trials evaluating this low-dose regimen in Alzheimer's disease and diabetic nephropathy.

What phase is PF-04494700- Low Dose Arm in?

PF-04494700- Low Dose Arm is in Phase 2 clinical development. All trials for this drug candidate have been completed, and no active trials are currently ongoing. It is an investigational therapy and has not been approved by the FDA.

What clinical trials is PF-04494700- Low Dose Arm in?

PF-04494700- Low Dose Arm has been evaluated in three completed Phase 2 trials: NCT00566397 in mild to moderate Alzheimer's disease (402 patients), NCT00287183 in type 2 diabetes with persistent albuminuria (110 patients), and NCT00141661 in Alzheimer's patients (67 patients). Total enrollment across these trials was 469 participants.

Is PF-04494700- Low Dose Arm the same as PF-04494700?

Yes, PF-04494700- Low Dose Arm is a specific dosing group of PF-04494700, also known as TTP488. The low-dose arm refers to the lower dosage regimen tested within the broader clinical program for this drug candidate.