Cognitive DeclineNCT00099567
Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline
An observational study of Cognitive Decline, run by National Institute on Aging (NIA) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- How many people
- 2,632 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 1997to Dec 2002
- 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 70 to 79 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Memphis, Tennessee
Study site
Pittsburgh, Pennsylvania
About this study
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.
Read the detailed description
The metabolic syndrome is a clustering of several commonly occurring disorders that include abdominal obesity, high triglycerides, low HDL cholesterol, high blood pressure, and insulin resistance. This study was conducted to determine if, as hypothesized, the presence of the metabolic syndrome is associated with more cognitive decline and greater risk of developing cognitive impairment, and whether this risk is affected by the level of inflammatory markers in the blood.
This 5-year prospective observational study was conducted from 1997 to 2002 at community clinics in two locations. A total of 2632 black and white participants, aged 70 to 79 years, were recruited from the 3075 participants in the Health, Aging and Body Composition (ABC) study conducted during the same period. Participants were screened for presence of metabolic syndrome, cognitive status, inflammatory markers, and a clinic examination was administered, when the study began and at the year 3 and 5 follow-up visits.
- Conditions
- Cognitive Decline
- Keywords
- Metabolic Syndrome, Alzheimer's Disease, Cognitive Impairment, Inflammation
- Medical subject headings
- Cognitive Dysfunction, Metabolic Syndrome, Alzheimer Disease, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2004 (estimated)
- Study startJan 1997
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Natural history
- Time perspective
- Prospective
- Enrolment
- 2,632 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Paul Beeson Faculty Scholars Program, University of California, San Francisco
- Investigators
- Kristine Yaffe, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099567
- Sponsor's protocol ID
- IA0066
- Other IDs
- 1N01AG062106, 1R01AG021918
- Status last verified
- Dec 2004
- First submitted
- 16 Dec 2004
- Last updated
- 1 Nov 2005
- Results posted
- No
Publications
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.
PubMed 12847160Kalmijn 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.
PubMed 11031212Yaffe 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.
PubMed 15536110
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline
- ClinicalTrials.gov ID
- NCT00099567
- Acronym / sponsor ID
- IA0066
- Conditions
- Cognitive Decline
- Keywords
- Metabolic Syndrome, Alzheimer's Disease, Cognitive Impairment, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,632 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- Paul Beeson Faculty Scholars Program, University of California, San Francisco
- Study start
- Jan 1997
- Study completion
- Dec 2002
- First posted
- 17 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The metabolic syndrome is a clustering of several commonly occurring disorders that include abdominal obesity, high triglycerides, low HDL cholesterol, high blood pressure, and insulin resistance. This study was conducted to determine if, as hypothesized, the presence of the metabolic syndrome is associated with more cognitive decline and greater risk of developing cognitive impairment, and whether this risk is affected by the level of inflammatory markers in the blood.
This 5-year prospective observational study was conducted from 1997 to 2002 at community clinics in two locations. A total of 2632 black and white participants, aged 70 to 79 years, were recruited from the 3075 participants in the Health, Aging and Body Composition (ABC) study conducted during the same period. Participants were screened for presence of metabolic syndrome, cognitive status, inflammatory markers, and a clinic examination was administered, when the study began and at the year 3 and 5 follow-up visits.
Study design
- Observational model
- Natural history
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2005.
- Background: PubMed 12847160Yaffe 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.
- Background: PubMed 11031212Kalmijn 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.
- Results publication: PubMed 15536110Yaffe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Yaffe, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Decline, run by National Institute on Aging (NIA) at 2 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 1 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00099567, which also lists 3 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 1 Nov 2005.