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Study Evaluating GSI-953 in Healthy Young and Alzheimer's Patients

Last updated on November 19, 2019

FOR MORE INFORMATION
Study Location
Glendale, California, 91206 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
Disease. (same as above)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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
Disease. (same as above)

NCT00479219
Pfizer
Completed
Study Evaluating GSI-953 in Healthy Young and Alzheimer's Patients

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Descriptive Information
Brief Title  ICMJE Study Evaluating GSI-953 in Healthy Young and Alzheimer's Patients
Official Title  ICMJE A Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI-953 in Blood and Cerebrospinal Fluid, When Administered Orally to Healthy Young Subjects and Patients With Alzheimer Disease
Brief SummaryTo assess the pharmacodynamics (PD) of biomarkers amyloid beta peptide 40 and 42 (Ab40 and Ab42) in CSF, following single oral doses of GSI-953, an investigational drug, in healthy young subjects and patients with Alzheimer Disease (AD).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: GSI-953
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: GSI-953
  • Placebo Comparator: B
    Intervention: Other: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2008)
17
Original Enrollment  ICMJE
 (submitted: May 25, 2007)
40
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion DateOctober 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 Disease. (same as above)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00479219
Other Study ID Numbers  ICMJE 3183A1-103
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJuly 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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