Back to resultsStudy Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SRA-333
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility 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
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00151333
First Posted
September 6, 2005
Last Updated
September 3, 2009
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00151333
Brief Title
Study Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To determine the safety and tolerability of multiple ascending fixed oral doses of SRA-333 in subjects with mild to moderate Alzheimer's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SRA-333
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of multiple ascending fixed oral dose in subject with mild to moderate Alzheimer's Disease
Secondary Outcome Measure Information:
Title
To assess the pharmacokinetics and pharmacodynamics of multiple ascending fixed dose.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33154
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)
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