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

Last updated on May 10, 2018

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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Study Evaluating GSI-953 in Healthy Young and Alzheimer's Patients
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
To 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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: GSI-953
  • Other: Placebo
  • Experimental: A
    Intervention: Drug: GSI-953
  • Placebo Comparator: B
    Intervention: Other: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
October 2007
October 2007   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00479219
3183A1-103
Not Provided
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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