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Study Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: September 6, 2005
Last updated: September 3, 2009
Last verified: September 2009
To determine the safety and tolerability of multiple ascending fixed oral doses of SRA-333 in subjects with mild to moderate Alzheimer's disease.

Condition Intervention Phase
Alzheimer's Disease
Drug: SRA-333
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics Trial of Multiple Ascending Fixed Doses of SRA-333 in Subjects With Mild to Moderate Alzheimer's Disease.

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To determine the safety and tolerability of multiple ascending fixed oral dose in subject with mild to moderate Alzheimer's Disease

Secondary Outcome Measures:
  • To assess the pharmacokinetics and pharmacodynamics of multiple ascending fixed dose.

Estimated Enrollment: 16
Study Start Date: February 2005
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of probable AD according to the NINCDS-ADRDA criteria.
  • Men and postmenopausal or surgically sterile women aged from 50 to 85 inclusive.
  • Able to give informed consent. Patient's caregiver must consent to participate in the study.

Exclusion Criteria:

  • Significant neurologic disease other than AD that may affect cognition.
  • Current clinically significant systemic illness which is likely to deteriorate or affect the subject's safety during the study.

Other exclusions apply

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Please refer to this study by its identifier: NCT00151333

United States, Arizona
Phoenix, Arizona, United States, 85013
United States, Florida
Ft. Lauderdale, Florida, United States, 33321
Miami, Florida, United States, 33154
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information Identifier: NCT00151333     History of Changes
Other Study ID Numbers: 3098A1-200
Study First Received: September 6, 2005
Last Updated: September 3, 2009

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on May 25, 2017