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

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).

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

GSI-953

Drug

Placebo

Other

Primary outcomes

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.

Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: May 28, 2007
Registry last updated: Jul 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed