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

NCT ID: NCT00479219

Last Updated: 2008-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

GSI-953

Intervention Type DRUG

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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GSI-953

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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3183A1-103

Identifier Type: -

Identifier Source: org_study_id