NCT00007189

Brief Summary

The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
2,625

participants targeted

Target at P75+ for phase_3 alzheimer-disease

Geographic Reach
1 country

6 active sites

Status
completed

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

First Submitted

Initial submission to the registry

December 14, 2000

Completed
Same day until next milestone

First Posted

Study publicly available on registry

December 14, 2000

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2001

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

6.3 years

First QC Date

December 14, 2000

Last Update Submit

October 18, 2016

Conditions

Alzheimer Disease

Keywords

Alzheimer diseaseAnti-inflammatory drugs

Interventions

Naproxen Sodium (Aleve)DRUG
Celecoxib (Celebrex)DRUG

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 70 years or older.
  • Family history of parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or Alzheimer's disease.
  • Study partner available to provide information on the cognitive status of the participant and to assist with monitoring of trial medications, if needed.
  • Sufficient fluency in written and spoken English to participate in study visits and neuropsychological testing.
  • Willingness to limit use of the following for the duration of the study: vitamin E (at doses greater than 400 IU per day), non-aspirin NSAIDs, histamine H2 receptor antagonists (Tagamet, for example), corticosteroids, anti-inflammatory or analgesic doses of aspirin (greater than 81 mg per day), Ginkgo biloba extracts
  • Ability and intention to participate in regular study visits, in the opinion of the study physician.
  • Provision of informed consent.

You may not qualify if:

  • History of peptic ulcer disease with bleeding or obstruction.
  • Clinically significant liver or kidney disease.
  • History of hypersensitivity to aspirin, ibuprofen, celecoxib, naproxen, or other NSAIDs.
  • Use of anti-coagulant medication.
  • Cognitive impairment or dementia.
  • Current alcohol abuse or dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

Roskamp Institute Memory Clinic, 10770 N. 46th Street

Tampa, Florida, 33617, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

University of Rochester

Rochester, New York, 14620, United States

Location

Veterans Affairs Puget Sound Health Care System, University of Washington

Seattle, Washington, 98108, United States

Location

Related Publications (9)

  • Anthony JC, Breitner JC, Zandi PP, Meyer MR, Jurasova I, Norton MC, Stone SV. Reduced prevalence of AD in users of NSAIDs and H2 receptor antagonists: the Cache County study. Neurology. 2000 Jun 13;54(11):2066-71. doi: 10.1212/wnl.54.11.2066.

    PMID: 10851364BACKGROUND

  • Breitner JC. The role of anti-inflammatory drugs in the prevention and treatment of Alzheimer's disease. Annu Rev Med. 1996;47:401-11. doi: 10.1146/annurev.med.47.1.401.

    PMID: 8712791BACKGROUND

  • McGeer PL, Schulzer M, McGeer EG. Arthritis and anti-inflammatory agents as possible protective factors for Alzheimer's disease: a review of 17 epidemiologic studies. Neurology. 1996 Aug;47(2):425-32. doi: 10.1212/wnl.47.2.425.

    PMID: 8757015BACKGROUND

  • 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: 17460158RESULT

  • 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: 17111043RESULT

  • Drye LT, Casper AS, Sternberg AL, Holbrook JT, Jenkins G, Meinert CL. The transitioning from trials to extended follow-up studies. Clin Trials. 2014 Dec;11(6):635-47. doi: 10.1177/1740774514547396. Epub 2014 Aug 12.

    PMID: 25115882DERIVED

  • 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

  • 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: 18474729DERIVED

  • Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. doi: 10.1161/CIRCULATIONAHA.108.764530. Epub 2008 Mar 31.

    PMID: 18378608DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

NaproxenCelecoxib

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsBenzenesulfonamidesSulfonamidesAmidesBenzene DerivativesSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • John C Breitner, MD, MPH

    Professor and Head, Division of Geriatric Psychiatry, University of Washington School of Medicine; and Director, GRCC, VA Puget Sound Health Care System, Seattle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2000

First Posted

December 14, 2000

Study Start

January 1, 2001

Primary Completion

May 1, 2007

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

US(6)