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AlzRisk Cohort Detail

Cohort: Alzheimer's Disease Anti-inflammatory Prevention Trial
Risk Factors:

Introduction to the Cohort
ADAPT was designed to was designed to address whether NSAIDs can prevent or delay the onset of Alzheimer's disease. This was a randomized, multi-center, phase 4, double-masked, placebo-controlled, primary-prevention trial conducted at 6 U.S. dementia centers. Participants were at least 70 years old and have a parent, brother, or sister who has, or had, a serious age-related memory loss, senility, dementia or Alzheimer's disease. Participants took anti-inflammatory medication or placebo (inactive pill) twice daily [celecoxib (200 mg twice daily), naproxen sodium (220 mg twice daily), or placebo, randomly allocated in a ratio of 1:1:1.5, respectively]. The trial began in 2001 but was suspended in December 2004 as precautionary measure due to potential adverse cardiovascular effects of celecoxib.

Participants attended study site visits for a medical evaluation every six months and participated in a telephone interview twice a year for a planned average of up to seven years of follow-up. A total of 2528 participants were enrolled in ADAPT from March 2001 to December 2004, and 2117 contributed follow-up cognitive measures from baseline to up to 6 months after study treatment cessation. Investigators and participants continued the double-masked ADAPT protocol for 2 additional years to investigate incidence of AD.

Ethnicity Breakdown
The majority of participants were white (97%), followed by 0.7% African-American.

Diagnosis & Evaluation Methods
For a detailed description, see ADAPT Research Group, et al. 2009.

Breitner JC, Baker LD, Montine TJ, Meinert CL, Lyketsos CG, Ashe KH, Brandt J, Craft S, Evans DE, Green RC, Ismail MS, Martin BK, Mullan MJ, Sabbagh M, Tariot PN,ADAPT Research Group. Extended results of the Alzheimer's disease anti-inflammatory prevention trial.Alzheimers Dement. 2011 Jul;7(4):402-11.

ADAPT Research Group, Meinert CL, McCaffrey LD, Breitner JC .Alzheimer's Disease Anti-inflammatory Prevention Trial: design, methods, and baseline results. Alzheimers Dement. 2009 Mar;5(2):93-104.

ADAPT Research Group, Martin BK, Szekely C, Brandt J, Piantadosi S, Breitner JC, Craft S, Evans D, Green R, Mullan M. Cognitive function over time in the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT): results of a randomized, controlled trial of naproxen and celecoxib. Arch Neurol. 2008 Jul;65(7):896-905. Epub 2008 May 12.

ADAPT Research Group, Lyketsos CG, Breitner JC, Green RC, Martin BK, Meinert C, Piantadosi S, Sabbagh M. Naproxen and celecoxib do not prevent AD in early results from a randomized controlled trial. Neurology. 2007 May 22;68(21):1800-8. Epub 2007 Apr 25.