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PF-04494700

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Nov 30, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment402

FDA Designations

No designations recorded

Clinical trial landscape

PF-04494700 · 2 trials · 2 indications

Phase 2 2
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
PHASE2COMPLETED
A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease
Alzheimer's Disease
NCT00566397402
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PHASE2COMPLETED
6-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent Albuminuria
Diabetic Nephropathy
NCT00287183110
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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).

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 -

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
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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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Competitive Landscape -Alzheimer's Disease 66 trials

Top 20 of 24 competitors

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC
Eli Lilly and CompanyLLY12PHASE3Donanemab, Dexamethasone
Biogen Inc.BIIB2PHASE3Lecanemab
Annovis Bio IncANVS1PHASE3buntanetap/posiphen
ACADIA Pharmaceuticals Inc.ACAD2PHASE3ACP-204
Novartis AG Sponsored ADRNVS2PHASE2VHB937
GSK plc Sponsored ADRGSK2PHASE2GSK4527226
Cognition Therapeutics, Inc.CGTX2PHASE2CT1812
Johnson & JohnsonJNJ1PHASE2JNJ-64042056
Merck & Co., Inc.MRK1PHASE2MK-2214
Lantheus Holdings IncLNTH2PHASE3Nilotinib BE
Acumen Pharmaceuticals, Inc.ABOS1PHASE2sabirnetug
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
IGC Pharma, Inc.IGC1PHASE2IGC-AD1-Active
Alnylam Pharmaceuticals, IncALNY2PHASE1ALN-5288
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-MAPT
AC Immune SAACIU2PHASE1ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a, ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b, ACI-24.060 at Dose A in Study Part 2
Denali Therapeutics Inc.DNLI1PHASE1DNL628
Alzamend Neuro, Inc.ALZN1PHASE1ALZN002
Voyager Therapeutics, Inc.VYGR1PHASE1VY7523
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Frequently asked questions about PF-04494700

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.