NCT00315575

Brief Summary

The purpose of this study is to develop imaging techniques that can distinguish functional brain changes in people at high risk for dementia years prior to onset of clinical memory problems from those with normal changes of aging.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

August 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

January 26, 2009

Status Verified

January 1, 2009

Enrollment Period

2.9 years

First QC Date

April 14, 2006

Last Update Submit

January 22, 2009

Conditions

Alzheimer's Disease

Keywords

Dementiabrain circulationdisease /disorder proneness /riskneuropathologyneurophysiologyagingapolipoprotein Egenotypehemodynamicsmemorytemporal lobe /cortex

Outcome Measures

Primary Outcomes (1)

  • identification of consistent patterns of variance in brain function in subjects at risk for Alzheimer's Disease by using APOE ε4 as a marker for disease risk

    single time point

Study Arms (2)

1

Individuals with high risk for Alzheimer's disease

Procedure: BOLD and Perfusion brain MRI

2

Individuals with low risk for Alzheimer's disease

Procedure: BOLD and Perfusion brain MRI

Interventions

BOLD and Perfusion brain MRIPROCEDURE

Blood oxygenation and perfusion functional MRI performed twice, two weeks apart; each scan lasts 1 hour

12

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy adults from the community

You may qualify if:

  • Right-handed

You may not qualify if:

  • Major medical illnesses
  • History of significant head trauma with residual cognitive deficits
  • Other neurological or major psychiatric disorders such as schizophrenia, bipolar disorder, developmental learning disorder, and alcohol or substance abuse
  • MRI contra-indications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiley-Marcos Alzheimer's Disease Research Center, University of California, San Diego

La Jolla, California, 92037, United States

Location

Related Publications (4)

  • Bookheimer SY, Strojwas MH, Cohen MS, Saunders AM, Pericak-Vance MA, Mazziotta JC, Small GW. Patterns of brain activation in people at risk for Alzheimer's disease. N Engl J Med. 2000 Aug 17;343(7):450-6. doi: 10.1056/NEJM200008173430701.

    PMID: 10944562BACKGROUND

  • Mayeux R, Ottman R, Tang MX, Noboa-Bauza L, Marder K, Gurland B, Stern Y. Genetic susceptibility and head injury as risk factors for Alzheimer's disease among community-dwelling elderly persons and their first-degree relatives. Ann Neurol. 1993 May;33(5):494-501. doi: 10.1002/ana.410330513.

    PMID: 8498827BACKGROUND

  • Fleisher AS, Houston WS, Eyler LT, Frye S, Jenkins C, Thal LJ, Bondi MW. Identification of Alzheimer disease risk by functional magnetic resonance imaging. Arch Neurol. 2005 Dec;62(12):1881-8. doi: 10.1001/archneur.62.12.1881.

    PMID: 16344346BACKGROUND

  • Fleisher A, Grundman M, Jack CR Jr, Petersen RC, Taylor C, Kim HT, Schiller DH, Bagwell V, Sencakova D, Weiner MF, DeCarli C, DeKosky ST, van Dyck CH, Thal LJ; Alzheimer's Disease Cooperative Study. Sex, apolipoprotein E epsilon 4 status, and hippocampal volume in mild cognitive impairment. Arch Neurol. 2005 Jun;62(6):953-7. doi: 10.1001/archneur.62.6.953.

    PMID: 15956166BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseDementiaDisease Susceptibility

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Adam Fleisher, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 18, 2006

Study Start

August 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

January 26, 2009

Record last verified: 2009-01

Locations

US(1)