Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)
The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.
Drug: Naproxen Sodium (Aleve)
Drug: Celecoxib (Celebrex)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)|
|Study Start Date:||January 2001|
Considerable evidence suggests that inflammation may play a role in the neurodegenerative process of Alzheimer's disease (AD), and the use of non-steroidal anti-inflammatory drugs may be associated with reduced occurrence of AD. ADAPT is a randomized trial that will test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline. This long-term trial will run for 5 to 7 years.
The study is sponsored by the National Institute on Aging and is being conducted at the Roskamp Institute in Tampa, FL; the Veterans Affairs Puget Sound Health Care System with the University of Washington, in Seattle, WA; Boston University School of Medicine, in Boston, MA; the Johns Hopkins Medical Institutions, in Baltimore, MD; Sun Health Research Institute, in Phoenix, AZ; and the University of Rochester, in Rochester, NY. At each of these six sites, the goal is the enroll approximately 700 men and women, totalling 2,625 participants. Participants must be 70 years of age or older, have a parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or Alzheimer's disease.
Participants will be asked to take an anti-inflammatory medication or placebo (inactive pill) twice daily. Before enrolling in the trial, participants will be asked to go to a study site for two medical evaluations. Once enrolled, they will need to go to a study site for a medical evaluation every six months and to participate in a telephone interview twice a year for an average of up to seven years of follow-up.
|United States, Arizona|
|Sun Health Research Institute|
|Sun City, Arizona, United States, 85351|
|United States, Florida|
|Roskamp Institute Memory Clinic, 10770 N. 46th Street|
|Tampa, Florida, United States, 33617|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Boston University School of Medicine|
|Boston, Massachusetts, United States, 02118|
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14620|
|United States, Washington|
|Veterans Affairs Puget Sound Health Care System, University of Washington|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||John C Breitner, MD, MPH||Professor and Head, Division of Geriatric Psychiatry, University of Washington School of Medicine; and Director, GRCC, VA Puget Sound Health Care System, Seattle|