- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000178
Multicenter Trial of Prednisone in Alzheimer's Disease
June 23, 2005 updated by: National Institute on Aging (NIA)
This is a randomized placebo controlled, double blind study.
Patients who meet eligibility criteria and decide to participate in the study will be randomly assigned to receive either drug treatment or a placebo.
Neither the patients nor the participating investigators will know who is receiving the drugs and who is receiving the placebo.
Participation involves 15 outpatient clinic visits over a 68 week period.
Patients take study medication at varying doses (the maximum dose is 20 mg daily), along with calcium and vitamin supplements.
Study Overview
Study Type
Interventional
Phase
- Phase 3
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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Alabama
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Birmingham, Alabama, United States, 35294-0017
- University of Alabama, Birmingham
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California
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Los Angeles, California, United States, 90033
- University of Southern California
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San Diego, California, United States, 92093-0949
- University of California, San Diego
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Florida
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Jacksonville, Florida, United States, 32225
- Mayo Clinic Jacksonville
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Miami, Florida, United States, 33140
- University of Miami
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Tampa, Florida, United States, 33162
- University of South Florida
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Alzheimer's Center
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins University
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University
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New York
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New York, New York, United States, 10016
- New York University Medical Center
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New York, New York, United States, 10029
- Mount Sinai Medical Center
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New York, New York, United States, 11032
- Columbia Presbyterian Medical Center
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Rochester, New York, United States, 14620
- University of Rochester
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White Plains, New York, United States, 10605
- Burke Medical Research Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Tennessee
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Nashville, Tennessee, United States, 37212-8646
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, United States, 75235-9070
- University of Texas
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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
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with Alzheimer's disease who are in stable medical condition
Exclusion Criteria:
- Patients with diabetes or severe osteoporosis
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
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Leon Thal, MD., University of California, San Diego
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 Registration Dates
First Submitted
October 29, 1999
First Submitted That Met QC Criteria
October 29, 1999
First Posted (Estimate)
November 1, 1999
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
February 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisone
Other Study ID Numbers
- IA0002
- 3U01AG010483-08S2 (U.S. NIH Grant/Contract)
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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