Clinical trial NCT00315575: Memory Imaging of Normal Aging
Official title: BOLD and Perfusion fMRI of Alzheimer's Disease Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Dementia
brain circulation
disease /disorder proneness /risk
neuropathology
neurophysiology
aging
apolipoprotein E
genotype
hemodynamics
memory
temporal lobe /cortex
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 2006-04-18
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adults from the community

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: single time point
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Shiley-Marcos Alzheimer's Disease Research Center, University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Adam Fleisher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.