NCT00099567

Brief Summary

The purpose of this study is to determine if the metabolic syndrome is a risk factor for cognitive decline and if this association is modified by inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,632

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1997

Longer than P75 for all trials

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

January 1, 1997

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2004

Completed
Last Updated

November 1, 2005

Status Verified

December 1, 2004

First QC Date

December 16, 2004

Last Update Submit

October 31, 2005

Conditions

Cognitive Decline

Keywords

Metabolic SyndromeAlzheimer's DiseaseCognitive ImpairmentInflammation

Eligibility Criteria

Age70 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 70 to 79
  • White or Black
  • Community-dwelling in Memphis, TN or Pittsburgh, PA vicinity
  • Well-functioning (no difficulty in walking a quarter of a mile or going up 10 steps without resting)

You may not qualify if:

  • Any difficulty with activities of daily living
  • Clinical dementia
  • Inability to communicate with interviewer
  • Intention of moving out of vicinity in the next year
  • Active treatment for cancer in the previous 3 years
  • Participation in a trial involving a lifestyle intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Related Publications (3)

  • Yaffe K, Lindquist K, Penninx BW, Simonsick EM, Pahor M, Kritchevsky S, Launer L, Kuller L, Rubin S, Harris T. Inflammatory markers and cognition in well-functioning African-American and white elders. Neurology. 2003 Jul 8;61(1):76-80. doi: 10.1212/01.wnl.0000073620.42047.d7.

    PMID: 12847160BACKGROUND

  • Kalmijn S, Foley D, White L, Burchfiel CM, Curb JD, Petrovitch H, Ross GW, Havlik RJ, Launer LJ. Metabolic cardiovascular syndrome and risk of dementia in Japanese-American elderly men. The Honolulu-Asia aging study. Arterioscler Thromb Vasc Biol. 2000 Oct;20(10):2255-60. doi: 10.1161/01.atv.20.10.2255.

    PMID: 11031212BACKGROUND

  • Yaffe K, Kanaya A, Lindquist K, Simonsick EM, Harris T, Shorr RI, Tylavsky FA, Newman AB. The metabolic syndrome, inflammation, and risk of cognitive decline. JAMA. 2004 Nov 10;292(18):2237-42. doi: 10.1001/jama.292.18.2237.

    PMID: 15536110RESULT

MeSH Terms

Conditions

Cognitive DysfunctionMetabolic SyndromeAlzheimer DiseaseInflammation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kristine Yaffe, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

December 16, 2004

First Posted

December 17, 2004

Study Start

January 1, 1997

Study Completion

December 1, 2002

Last Updated

November 1, 2005

Record last verified: 2004-12

Locations

US(2)