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Alzheimer DiseaseADAPT-FSNCT01417130

Follow-up Study of the Alzheimer's Disease Anti-Inflammatory Prevention Trial

An observational study of Alzheimer Disease and Dementia, run by Seattle Institute for Biomedical and Clinical Research at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Alzheimer Disease, Dementia
How many people
1,650 participants
Where
6 sitesUnited States
Study dates
Aug 2009to Aug 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • Subjects must have been enrolled previously in the Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT).

Who cannot join

  • Individuals not previously enrolled in the ADAPT trial.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • The Johns Hopkins University

    Baltimore, Maryland, 21205

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

  • Monroe Community Hospital

    Rochester, New York, 14620

  • The Roskamp Institute

    Sarasota, Florida, 34243

  • Veterans Affairs Puget Sound Health Care System

    Seattle, Washington, 98108

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

Other trials in United States

About this study

Official title: Alzheimer's Disease Anti-Inflammatory Prevention Trial Follow-Up Study

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.

Read the 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.

Keywords
Naproxen, Celecoxib, Anti-Inflammatory Agents, Non-Steroidal
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01417130
Study groupRoleWhat they receive
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
PlaceboOriginal assignment in the ADAPT trial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incident Alzheimer's Disease dementia

    Incidence

    Measured: Up to 9 years.

Secondary outcomes (1)

  1. Trajectory of performance on cognitive tests in relation to ADAPT treatment assignment

    Telephone Interview for Cognitive Status (TICS), Rivermead Behavioral Memory Test (RBMT), Generative Verbal Fluency (GVF)

    Measured: Up to 9 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2011 (estimated)
  2. Study startAug 2009
  3. Primary completionOct 2011
  4. Study completionAug 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01417130
Sponsor's protocol ID
BREITNERBJ18CO
Other IDs
5U01AG015477-07
Acronym
ADAPT-FS
Status last verified
Jan 2012
First submitted
24 Jun 2011
Last updated
9 Jan 2012
Results posted
No
Data monitoring committee
No

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. doi: 10.1212/01.wnl.0000260269.93245.d2. Epub 2007 Apr 25.

    PubMed 17460158

  • 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.

    PubMed 17111043

  • 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.

    PubMed 18474729

  • 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.

    PubMed 18827048

  • 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.

    PubMed 17349436

  • 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.

    PubMed 17349430

  • 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.

    PubMed 17192795

  • 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.

    PubMed 11852171

  • 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.

    PubMed 25022541

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer Disease and Dementia, run by Seattle Institute for Biomedical and Clinical Research at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incident Alzheimer's Disease dementia (time frame: Up to 9 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01417130, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2012.

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