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GSI-953

Phase 1

Alzheimer Disease | Small molecule | Neurology |Pfizer, Inc.|Trials Updated: Jul 10, 2008

GSI-953 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Mar 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

GSI-953 clinical trials

GSI-953 · 1 trial · 1 indication

Phase 1 1
NCT00479219Study Evaluating GSI-953 in Healthy Young and Alzheimer's PatientsAlzheimer Disease
COMPLETED17 Analytics
PHASE1COMPLETED
Study Evaluating GSI-953 in Healthy Young and Alzheimer's Patients
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

We will assess the pharmacodynamics (PD) of biomarkers amyloid beta 40 and 42 in CSF, following single oral doses of GSI-953 in healthy young and Alzheimer's Patients.
5 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
GSI-953DRUG -
PlaceboOTHER -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * For Healthy Young Subjects: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12 lead ECGs. * For AD patients: Patients must be generally healthy with the exception of Alzheimer Di...

Countries:United States
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Frequently asked questions about GSI-953

What is GSI-953?

GSI-953 is an investigational small molecule being developed by Pfizer, Inc. for Alzheimer disease. It is a neurology asset that has been studied in a Phase 1 clinical trial. GSI-953 is not approved and remains in early clinical development.

What is GSI-953 used for?

GSI-953 is being studied for the treatment of Alzheimer disease. The only clinical trial of GSI-953 listed to date enrolled participants with Alzheimer disease along with healthy volunteers. It is an investigational therapy and has not been approved for any use.

Who makes GSI-953?

GSI-953 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of GSI-953 conducted in the United States.

What phase is GSI-953 in?

GSI-953 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. GSI-953 is investigational and has not been approved by the FDA for Alzheimer disease or any other indication.

What clinical trials is GSI-953 in?

GSI-953 has been evaluated in one completed Phase 1 trial, NCT00479219, titled Study Evaluating GSI-953 in Healthy Young and Alzheimer's Patients. That trial enrolled 17 participants in the United States, was randomized, double blind, and placebo controlled, and included healthy volunteers.

How many patients were enrolled in GSI-953 trials?

The completed Phase 1 trial of GSI-953, NCT00479219, enrolled 17 participants. It was a randomized, double blind, placebo controlled study that included both healthy young volunteers and patients with Alzheimer disease, and it was conducted in the United States.