Follow-up Study of the Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT-FS)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Alzheimer Disease; Dementia

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

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Study Type :	Observational
Estimated Enrollment :	1650 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Alzheimer's Disease Anti-Inflammatory Prevention Trial Follow-Up Study
Study Start Date :	August 2009
Actual Primary Completion Date :	October 2011
Estimated Study Completion Date :	August 2012

Groups and Cohorts

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Group/Cohort
Naproxen sodium (220 mg b.i.d); Original assignment in the ADAPT trial
Celecoxib (200 mg b.i.d.); Original assignment in the ADAPT trial
Placebo; Original assignment in the ADAPT trial

Outcome Measures

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Primary Outcome Measures :

1. Incident Alzheimer's Disease dementia [ Time Frame: Up to 9 years. ]
   Incidence

Secondary Outcome Measures :

1. Trajectory of performance on cognitive tests in relation to ADAPT treatment assignment [ Time Frame: Up to 9 years. ]
   Telephone Interview for Cognitive Status (TICS), Rivermead Behavioral Memory Test (RBMT), Generative Verbal Fluency (GVF)

Biospecimen Retention:   Samples With DNA

Specimens retained from the ADAPT trial include plasma, serum, urine and cerebrospinal fluid (the latter from a smaller sample of volunteers). Additional collection of cerebrospinal fluid from prior donors and from a new panel of volunteers is conducted under a different sub-study of ADAPT.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	75 Years and older (Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Living members of the cohort previously enrolled in the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT)

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arizona
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, Florida
The Roskamp Institute
Sarasota, Florida, United States, 34243
United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, New York
Monroe Community Hospital
Rochester, New York, United States, 14620
United States, Washington
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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Alzheimer's Disease Anti-Inflammatory Prevention Trial 

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. 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.

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.

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.

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, 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:	NCT01417130 History of Changes
Other Study ID Numbers:	BREITNERBJ18CO; 5U01AG015477-07 ( U.S. NIH Grant/Contract )
First Posted:	August 16, 2011
Last Update Posted:	January 9, 2012
Last Verified:	January 2012

Keywords provided by Seattle Institute for Biomedical and Clinical Research:

Naproxen; Celecoxib; Anti-Inflammatory Agents, Non-Steroidal

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Celecoxib; Naproxen; Anti-Inflammatory Agents	Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antirheumatic Agents; Gout Suppressants