Follow-up Study of the Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT-FS)
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| ClinicalTrials.gov Identifier: NCT01417130 |
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Recruitment Status : Unknown
Verified January 2012 by Seattle Institute for Biomedical and Clinical Research.
Recruitment status was: Active, not recruiting
First Posted : August 16, 2011
Last Update Posted : January 9, 2012
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| Condition or disease |
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| Alzheimer Disease Dementia |
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 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 |
| Group/Cohort |
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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
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- Incident Alzheimer's Disease dementia [ Time Frame: Up to 9 years. ]Incidence
- 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
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| Ages Eligible for Study: | 75 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417130
| 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 | |
| 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 |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Key Record Dates |
| Last Update Posted: | January 9, 2012 |
| Last Verified: | January 2012 |
Keywords provided by Seattle Institute for Biomedical and Clinical Research:
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Naproxen Celecoxib Anti-Inflammatory Agents, Non-Steroidal |
Additional relevant MeSH terms:
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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 |