Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00151333
First received: September 6, 2005
Last updated: September 3, 2009
Last verified: September 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151333

Locations
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
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00151333     History of Changes
Other Study ID Numbers: 3098A1-200
Study First Received: September 6, 2005
Last Updated: September 3, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013