Memory Imaging of Normal Aging

• ClinicalTrials.gov Identifier: NCT00315575
• Recruitment Status: Completed
• First Posted: April 18, 2006
• Last Update Posted: January 26, 2009
• Sponsor: National Institute on Aging (NIA)
• Information provided by: National Institute on Aging (NIA)

Study Description

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.

Condition or disease	Intervention/treatment
Alzheimer's Disease	Procedure: BOLD and Perfusion brain MRI

Detailed Description:

The overall goals of this project are to identify consistent patterns of variance in brain function in patients at risk for Alzheimer's Disease by using APOE ε4 as a marker for disease risk. The activation Blood Oxygen Level Dependency (BOLD) signal will be compared to both resting and activation perfusion signals to assess the variability of cerebral blood flow as it relates to the BOLD signal. Each participant will be imaged on a 3T MRI scanner while performing an associate episodic memory task.

A total of 90 individuals will be recruited for this study. Participants will be non-demented, right handed, adults with or without at least one APOE ε4 allele. Groups will be split as follows: A) ages 25-39: non-ε4 (n=15); B) ages 25-39: +ε4 (n=15); C) ages 40-49: non-ε4 (n=15); D) ages 40-49: +ε4 (n=15);.E) ages 50-65: non-ε4: F) ages 50-65: +ε4 (n=15). These groups will be matched for mean age, mean years of education, gender distribution, as well as the presence or absence of a family history of AD in a first degree relative.

There will be 2 scanning sessions for each participant. Scan session #1 and Scan session #2 will be acquired within 2 weeks of each other and will take approximately one hour each.

Study Design

• Study Type: Observational
• Estimated Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: BOLD and Perfusion fMRI of Alzheimer's Disease Risk
• Study Start Date: August 2005
• Actual Primary Completion Date: July 2008
• Actual Study Completion Date: July 2008

Groups and Cohorts

Group/Cohort	Intervention/treatment
1; Individuals with high risk for Alzheimer's disease	Procedure: BOLD and Perfusion brain MRI; Blood oxygenation and perfusion functional MRI performed twice, two weeks apart; each scan lasts 1 hour
2; Individuals with low risk for Alzheimer's disease	Procedure: BOLD and Perfusion brain MRI; Blood oxygenation and perfusion functional MRI performed twice, two weeks apart; each scan lasts 1 hour

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: single time point ]

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

healthy adults from the community

Criteria

Inclusion Criteria:

• Right-handed

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, California

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

La Jolla, California, United States, 92037

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Adam Fleisher, MD; University of California, San Diego

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Adam Fleisher, MD, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT00315575
• Other Study ID Numbers: IA0092; 5K23AG024062-02 ( U.S. NIH Grant/Contract )
• First Posted: April 18, 2006
• Last Update Posted: January 26, 2009
• Last Verified: January 2009

Keywords provided by National Institute on Aging (NIA):

Dementia; brain circulation; disease /disorder proneness /risk; neuropathology; neurophysiology; aging; apolipoprotein E; genotype; hemodynamics; memory; temporal lobe /cortex

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders