Multicenter Trial of Prednisone in Alzheimer's Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

October 29, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000178 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Multicenter Trial of Prednisone in Alzheimer's Disease

Official Title ^ICMJE

Multicenter Trial of Prednisone in Alzheimer's Disease

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Condition ^ICMJE

Alzheimer Disease

Intervention ^ICMJE

Drug: Prednisone

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Patients with diabetes or severe osteoporosis

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000178

Responsible Party

Study ID Numbers ^ICMJE

IA0002, 3U01AG10483-08S2

Study Sponsor ^ICMJE

National Institute on Aging (NIA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Leon Thal, MD.

University of California, San Diego

Information Provided By

National Institute on Aging (NIA)

Verification Date

February 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP