Alzheimer DiseasePhase 3NCT00000178
Multicenter Trial of Prednisone in Alzheimer's Disease
A Phase 3 study testing Prednisone in people with Alzheimer Disease, run by National Institute on Aging (NIA) at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Prednisone
- How many people
- Not given
- Where
- 19 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Alzheimer's disease who are in stable medical condition
Who cannot join
- Patients with diabetes or severe osteoporosis
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Johns Hopkins University
Baltimore, Maryland, 21224
University of Alabama, Birmingham
Birmingham, Alabama, 35294-0017
University of Texas
Dallas, Texas, 75235-9070
Indiana University Alzheimer's Center
Indianapolis, Indiana, 46202
Mayo Clinic Jacksonville
Jacksonville, Florida, 32225
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Southern California
Los Angeles, California, 90033
University of Miami
Miami, Florida, 33140
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-8646
New York University Medical Center
New York, New York, 10016
Mount Sinai Medical Center
New York, New York, 10029
Columbia Presbyterian Medical Center
New York, New York, 11032
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Rochester
Rochester, New York, 14620
University of California, San Diego
San Diego, California, 92093-0949
Washington University
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33162
Burke Medical Research Institute
White Plains, New York, 10605
About this study
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.
- Conditions
- Alzheimer Disease
- Being tested
- Prednisone
- Keywords
- Alzheimer's disease, Prednisone, Anti-inflammatory agents
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 1999 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Leon Thal, MD., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000178
- Sponsor's protocol ID
- IA0002
- Other IDs
- 3U01AG010483-08S2
- Status last verified
- Feb 2005
- First submitted
- 29 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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. doi: 10.1212/wnl.54.3.588.
PubMed 10680787
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial of Prednisone in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00000178
- Acronym / sponsor ID
- IA0002
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's disease, Prednisone, Anti-inflammatory agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- First posted
- 1 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Alzheimer's disease who are in stable medical condition
Key exclusion criteria (1 listed)
- Patients with diabetes or severe osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Results publication: PubMed 10680787Aisen 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.
- The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leon Thal, MD. principal investigator
University of California, San Diego
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisone in people with Alzheimer Disease, run by National Institute on Aging (NIA) at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.