NCT01417130

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 9, 2012

Status Verified

January 1, 2012

Enrollment Period

2.2 years

First QC Date

June 24, 2011

Last Update Submit

January 5, 2012

Conditions

Alzheimer DiseaseDementia

Keywords

NaproxenCelecoxibAnti-Inflammatory Agents, Non-Steroidal

Outcome Measures

Primary Outcomes (1)

  • Incident Alzheimer's Disease dementia

    Incidence

    Up to 9 years.

Secondary Outcomes (1)

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

    Up to 9 years.

Study Arms (3)

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

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Individuals not previously enrolled in the ADAPT trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

The Roskamp Institute

Sarasota, Florida, 34243, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Monroe Community Hospital

Rochester, New York, 14620, United States

Location

Veterans Affairs Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Publications (9)

  • 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.

    PMID: 17460158BACKGROUND

  • 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.

    PMID: 17111043BACKGROUND

  • 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.

    PMID: 18474729BACKGROUND

  • 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.

    PMID: 18827048BACKGROUND

  • 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.

    PMID: 17349436BACKGROUND

  • 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.

    PMID: 17349430BACKGROUND

  • 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.

    PMID: 17192795BACKGROUND

  • 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.

    PMID: 11852171BACKGROUND

  • 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.

    PMID: 25022541DERIVED

Related Links

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.

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • John CS Breitner, MD, MPH

    Veteran Affairs Puget Sound Health Care System

    STUDY CHAIR

  • Laura D Baker, PhD

    Veteran Affairs Puget Sound Health Care System

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2011

First Posted

August 16, 2011

Study Start

August 1, 2009

Primary Completion

October 1, 2011

Study Completion

August 1, 2012

Last Updated

January 9, 2012

Record last verified: 2012-01

Locations

US(6)