- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00315575
Memory Imaging of Normal Aging
BOLD and Perfusion fMRI of Alzheimer's Disease Risk
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
California
-
La Jolla, California, Forenede Stater, 92037
- Shiley-Marcos Alzheimer's Disease Research Center, University of California, San Diego
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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
|
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Adam Fleisher, MD, University of California, San Diego
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IA0092
- 5K23AG024062-02 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med BOLD and Perfusion brain MRI
-
Brain SentinelUkendt
-
Brain SentinelAfsluttetEpilepsi | Generaliserede tonisk-kloniske anfaldForenede Stater
-
Brain SentinelAfsluttetEpilepsi | Generaliserede tonisk-kloniske anfaldForenede Stater
-
The University of Texas at DallasMeadows Foundation; Hoglund FoundationRekruttering
-
Brain SentinelNationwide Children's HospitalAfsluttet
-
Yanpeng LiAfsluttetObstruktiv søvnapnø-hypopnø-syndromKina
-
Imperial College LondonBiogen; InvicroAfsluttetInflammatorisk respons | Slagtilfælde, iskæmisk | Slagtilfælde, AkutDet Forenede Kongerige
-
University of RochesterRekrutteringBrystkræft kvinde | Kræftrelaterede kognitive vanskelighederForenede Stater
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyAfsluttetStadie III nyrecellekræft | Stadie IV nyrecellekræft | Stadie I nyrecellekræft | Stadie II nyrecellekræftForenede Stater
-
American College of RadiologyPennsylvania Department of HealthAfsluttetKolorektal neoplasma | Hepatisk neoplasmaForenede Stater