- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00315575
Memory Imaging of Normal Aging
BOLD and Perfusion fMRI of Alzheimer's Disease Risk
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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California
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La Jolla, California, Forente stater, 92037
- Shiley-Marcos Alzheimer's Disease Research Center, University of California, San Diego
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
1
Individuals with high risk for Alzheimer's disease
|
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
|
Blood oxygenation and perfusion functional MRI performed twice, two weeks apart; each scan lasts 1 hour
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: single time point
|
single time point
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Adam Fleisher, MD, University of California, San Diego
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IA0092
- 5K23AG024062-02 (U.S. NIH-stipend/kontrakt)
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