NCT00000178

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 1999

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 1999

Completed
Last Updated

June 24, 2005

Status Verified

February 1, 2005

First QC Date

October 29, 1999

Last Update Submit

June 23, 2005

Conditions

Keywords

Alzheimer's diseasePrednisoneAnti-inflammatory agents

Interventions

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Alzheimer's disease who are in stable medical condition

You may not qualify if:

  • Patients with diabetes or severe osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

University of Alabama, Birmingham

Birmingham, Alabama, 35294-0017, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California, San Diego

San Diego, California, 92093-0949, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32225, United States

Location

University of Miami

Miami, Florida, 33140, United States

Location

University of South Florida

Tampa, Florida, 33162, United States

Location

Indiana University Alzheimer's Center

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia Presbyterian Medical Center

New York, New York, 11032, United States

Location

University of Rochester

Rochester, New York, 14620, United States

Location

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212-8646, United States

Location

University of Texas

Dallas, Texas, 75235-9070, United States

Location

Related Publications (1)

  • 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. doi: 10.1212/wnl.54.3.588.

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Prednisone

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Leon Thal, MD.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 29, 1999

First Posted

November 1, 1999

Last Updated

June 24, 2005

Record last verified: 2005-02

Locations