Follow-up Study of the Alzheimer's Disease Anti-Inflammatory Prevention Trial
NCT ID: NCT01417130
Last Updated: 2012-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1650 participants
OBSERVATIONAL
2009-08-31
2012-08-31
Brief Summary
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Detailed Description
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This ADAPT Follow-up Study (ADAPT-FS) is following-up the participants originally enrolled in ADAPT after a further interval of four years, thereby identifying additional individuals with AD dementia in each treatment assignment group, and then using time-dependent methods to estimate and contrast incidence rates by treatment assignment. The study is also extending prior observations on trajectory of cognitive performance on several psychometric measures, thus testing the hypothesis of differences in such trajectory by treatment assignment in ADAPT.
ADAPT-FS is sponsored by the National Institute on Aging (NIA) and is being conducted at the Roskamp Institute in Tampa, FL; the Veterans Affairs Puget Sound Health Care System 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Naproxen sodium (220 mg b.i.d)
Original assignment in the ADAPT trial
No interventions assigned to this group
Celecoxib (200 mg b.i.d.)
Original assignment in the ADAPT trial
No interventions assigned to this group
Placebo
Original assignment in the ADAPT trial
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
75 Years
ALL
No
Sponsors
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VA Puget Sound Health Care System
FED
National Institute on Aging (NIA)
NIH
Johns Hopkins University
OTHER
Seattle Institute for Biomedical and Clinical Research
OTHER
Responsible Party
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Principal Investigators
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John CS Breitner, MD, MPH
Role: STUDY_CHAIR
Veteran Affairs Puget Sound Health Care System
Laura D Baker, PhD
Role: STUDY_DIRECTOR
Veteran Affairs Puget Sound Health Care System
Constantine Lyketsos, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
The Johns Hopkins University
Peter Zandi, PhD
Role: PRINCIPAL_INVESTIGATOR
The Johns Hopkins University
Denis Evans, MD
Role: PRINCIPAL_INVESTIGATOR
Rush Institute for Healthy Aging
Locations
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Banner Sun Health Research Institute
Sun City, Arizona, United States
The Roskamp Institute
Sarasota, Florida, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Monroe Community Hospital
Rochester, New York, United States
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States
Countries
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References
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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. doi: 10.1212/01.wnl.0000260269.93245.d2. Epub 2007 Apr 25.
ADAPT Research Group. Cardiovascular and cerebrovascular events in the randomized, controlled Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT). PLoS Clin Trials. 2006 Nov 17;1(7):e33. doi: 10.1371/journal.pctr.0010033.
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. doi: 10.1001/archneur.2008.65.7.nct70006. Epub 2008 May 12.
Meinert CL, Martin BK, McCaffrey LD, Breitner JC. Do we need to adjudicate major clinical events? Clin Trials. 2008;5(5):557; author reply 558. doi: 10.1177/1740774508096007. No abstract available.
Martin BK, Breitner JC, Evans D, Lyketsos CG, Meinert CL. The trialist, meta-analyst, and journal editor: lessons from ADAPT. Am J Med. 2007 Mar;120(3):192-3. doi: 10.1016/j.amjmed.2006.12.010. No abstract available.
Breitner J, Evans D, Lyketsos C, Martin B, Meinert C. ADAPT trial data. Am J Med. 2007 Mar;120(3):e3; author reply e5; discussion e7. doi: 10.1016/j.amjmed.2006.09.022. No abstract available.
Breitner JC, Martin BK, Meinert CL. The suspension of treatments in ADAPT: concerns beyond the cardiovascular safety of celecoxib or naproxen. PLoS Clin Trials. 2006 Dec 22;1(8):e41. doi: 10.1371/journal.pctr.0010041. No abstract available.
Martin BK, Meinert CL, Breitner JC; ADAPT Research Group. Double placebo design in a prevention trial for Alzheimer's disease. Control Clin Trials. 2002 Feb;23(1):93-9. doi: 10.1016/s0197-2456(01)00189-1.
ADAPT-FS Research Group. Follow-up evaluation of cognitive function in the randomized Alzheimer's Disease Anti-inflammatory Prevention Trial and its Follow-up Study. Alzheimers Dement. 2015 Feb;11(2):216-25.e1. doi: 10.1016/j.jalz.2014.03.009. Epub 2014 Jul 9.
Related Links
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Alzheimer's Disease Anti-Inflammatory Prevention Trial
Other Identifiers
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BREITNERBJ18CO
Identifier Type: -
Identifier Source: org_study_id
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