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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Other: Placebo; Drug: GSI-953

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479219

3183A1-103

Details and patient eligibility

About

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).

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

17 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: GSI-953

B

Placebo Comparator group

Treatment:

Other: Placebo