- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00151333
Study Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)
September 3, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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.
To determine the safety and tolerability of multiple ascending fixed oral doses of SRA-333 in subjects with mild to moderate Alzheimer's disease.
Study Overview
Study Type
Interventional
Enrollment
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85013
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Florida
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Ft. Lauderdale, Florida, United States, 33321
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Miami, Florida, United States, 33154
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the safety and tolerability of multiple ascending fixed oral dose in subject with mild to moderate Alzheimer's Disease
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Secondary Outcome Measures
Outcome Measure |
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To assess the pharmacokinetics and pharmacodynamics of multiple ascending fixed dose.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (Actual)
April 1, 2005
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
September 6, 2005
First Submitted That Met QC Criteria
September 6, 2005
First Posted (Estimate)
September 8, 2005
Study Record Updates
Last Update Posted (Estimate)
September 4, 2009
Last Update Submitted That Met QC Criteria
September 3, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3098A1-200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on SRA-333
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Wyeth is now a wholly owned subsidiary of PfizerCompleted
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AbbottCompleted
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Wyeth is now a wholly owned subsidiary of PfizerCompletedAlzheimer's DiseaseSweden
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Quigley Pharma, Inc.CompletedDiabetic NeuropathyUnited States
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Chong Kun Dang PharmaceuticalUnknownHypertension | DyslipidemiasKorea, Republic of
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AbbVieCompletedRelative BioavailabilityUnited Kingdom
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AbbVieCompleted
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AbbottAbbott Japan Co.,LtdCompleted
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AbbottCompleted