Alzheimer Disease Clinical Trial
Official title:
Multicenter Trial of Prednisone in Alzheimer's Disease
| NCT number | NCT00000178 |
| Other study ID # | IA0002 |
| Secondary ID | 3U01AG010483-08S |
| Status | Completed |
| Phase | Phase 3 |
| First received | October 29, 1999 |
| Last updated | June 23, 2005 |
| Verified date | February 2005 |
| Source | National Institute on Aging (NIA) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Federal Government |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patients with Alzheimer's disease who are in stable medical condition Exclusion Criteria: - Patients with diabetes or severe osteoporosis |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Johns Hopkins University | Baltimore | Maryland |
| United States | University of Alabama, Birmingham | Birmingham | Alabama |
| United States | University of Texas | Dallas | Texas |
| United States | Indiana University Alzheimer's Center | Indianapolis | Indiana |
| United States | Mayo Clinic Jacksonville | Jacksonville | Florida |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | University of Southern California | Los Angeles | California |
| United States | University of Miami | Miami | Florida |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Columbia Presbyterian Medical Center | New York | New York |
| United States | Mount Sinai Medical Center | New York | New York |
| United States | New York University Medical Center | New York | New York |
| United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | University of Rochester | Rochester | New York |
| United States | University of California, San Diego | San Diego | California |
| United States | Washington University | St. Louis | Missouri |
| United States | University of South Florida | Tampa | Florida |
| United States | Burke Medical Research Institute | White Plains | New York |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute on Aging (NIA) |
United States,
Aisen PS, Davis KL, Berg JD, Schafer K, Campbell K, Thomas RG, Weiner MF, Farlow MR, Sano M, Grundman M, Thal LJ. A randomized controlled trial of prednisone in Alzheimer's disease. Alzheimer's Disease Cooperative Study. Neurology. 2000 Feb 8;54(3):588-93 — View Citation
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