ADAPT-FS: Follow-up Study of the Alzheimer's Disease Anti-Inflammatory Prevention Trial
Study Details
Study Description
Brief Summary
The Alzheimer's Disease Anti-inflammatory Prevention Trial - Follow-up Study (ADAPT-FS) will continue observations of the declared primary outcomes of the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT) in the cohort previously established for that trial.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
ADAPT was a multicenter, randomized, placebo-controlled trial designed to test the safety and efficacy of naproxen and celecoxib for the primary prevention of Alzheimer's Disease (AD) dementia and for attenuation of age related cognitive decline in persons over 70 years of age. The ADAPT treatments were stopped on 17 December, 2004, after the substantial majority of participants had been given treatments over an interval of one to three years. Participants remained under observation until May, 2006, using double-masked methods of case identification that were identical to those of the original ADAPT protocol. Results from the entire period of observations in ADAPT were ambiguous and suggested a need for additional longitudinal data to learn whether the dual-inhibitor NSAID naproxen can effect a long-term reduction in the occurrence of AD dementia.
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Naproxen sodium (220 mg b.i.d) Original assignment in the ADAPT trial |
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Celecoxib (200 mg b.i.d.) Original assignment in the ADAPT trial |
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Placebo Original assignment in the ADAPT trial |
Outcome Measures
Primary Outcome Measures
- Incident Alzheimer's Disease dementia [Up to 9 years.]
Incidence
Secondary Outcome Measures
- Trajectory of performance on cognitive tests in relation to ADAPT treatment assignment [Up to 9 years.]
Telephone Interview for Cognitive Status (TICS), Rivermead Behavioral Memory Test (RBMT), Generative Verbal Fluency (GVF)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Subjects must have been enrolled previously in the Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT).
Exclusion Criteria:
- Individuals not previously enrolled in the ADAPT trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Banner Sun Health Research Institute | Sun City | Arizona | United States | 85351 |
2 | The Roskamp Institute | Sarasota | Florida | United States | 34243 |
3 | The Johns Hopkins University | Baltimore | Maryland | United States | 21205 |
4 | Boston University School of Medicine | Boston | Massachusetts | United States | 02118 |
5 | Monroe Community Hospital | Rochester | New York | United States | 14620 |
6 | Veterans Affairs Puget Sound Health Care System | Seattle | Washington | United States | 98108 |
Sponsors and Collaborators
- Seattle Institute for Biomedical and Clinical Research
- VA Puget Sound Health Care System
- National Institute on Aging (NIA)
- Johns Hopkins University
Investigators
- Study Chair: John CS Breitner, MD, MPH, Veteran Affairs Puget Sound Health Care System
- Study Director: Laura D Baker, PhD, Veteran Affairs Puget Sound Health Care System
- Principal Investigator: Constantine Lyketsos, MD, MHS, The Johns Hopkins University
- Principal Investigator: Peter Zandi, PhD, The Johns Hopkins University
- Principal Investigator: Denis Evans, MD, Rush Institute for Healthy Aging
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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