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- Ensayo clínico NCT00902499
Evolution of Memory Related Activity
Evolution of Memory-related fMRI Activation Over the Course of MCI and AD
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The development of biomarkers is now especially critical, as there are a number of promising disease-modifying therapies entering early phase clinical trials, with additional novel therapeutic strategies in development. It is essential to develop biomarkers that can detect a "signal of efficacy" over a relatively short time frame for use in Phase II trials. Ideally biomarkers are needed that can reliably detect the earliest brain alterations due to AD pathology, perhaps at a point when there is synaptic dysfunction but not yet widespread neuronal loss. Functional neuroimaging, in particular functional MRI (fMRI), has significant potential, having already shown promise in detecting regionally specific pharmacological effects on memory related neural activity, and as a sensitive marker of very early cognitive impairment.
This study, a parallel ancillary study of the Alzheimer's Disease Neuroimaging Initiative (ADNI), will first examine reproducibility of fMRI activation, using a face-name associative memory paradigm, and then the alterations in memory-related activation that occur over the course of MCI and mild AD. The study will also examine the relationship of fMRI activation to clinical variables, memory task performance, genotype, and other imaging techniques cross-sectionally and longitudinally, sampling at multiple time points over a 3-year period.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Meghan Frey
- Número de teléfono: 617-732-8085
- Correo electrónico: mfrey1@partners.org
Copia de seguridad de contactos de estudio
- Nombre: Caroline Sullivan
- Número de teléfono: 617-726-6212
- Correo electrónico: csullivan21@partners.org
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Reclutamiento
- Brigham and Women's Hospital
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Contacto:
- Meghan Frey
- Número de teléfono: 617-732-8085
- Correo electrónico: mfrey1@partners.org
-
Boston, Massachusetts, Estados Unidos, 02129
- Reclutamiento
- Massachusetts General Hospital
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Contacto:
- Caroline Sullivan
- Número de teléfono: 617-726-6212
- Correo electrónico: csullivan21@partners.org
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Ages 55-90
- General good health or stable medical problems
- Study partner/caregiver able to provide an independent evaluation of the participant's daily functioning
- No contraindications to MR scanning
- Modified Hachinski Ischemic Score ≤4
- Geriatric Depression Scale ≤10
Exclusion Criteria:
- Diagnosis of Parkinson's disease or other neurological illness
- Presence of clinically significant/uncontrolled medical conditions
- History of stroke, brain tumor, brain surgery, seizures, significant head trauma with loss of consciousness, depression or other psychiatric illness, alcohol or drug abuse in the past 2 years
- Significant uncorrectable visual impairment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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NC
Normal older controls, not cognitively impaired; MMSE 27-30 and performance above education adjusted cutoff scores on the Logical Memory II subscale (LM-II Delayed Paragraph Recall) of the Wechsler Memory Scale
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vMCI
Very mild cognitive impairment; less severe objective memory deficit, scoring .5 to 1.5 S.D. (standard deviation) below education adjusted norms on the LM-II
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sMCI
significant mild cognitive impairment; objective cut off of 1.5 S.D. level below education adjusted norms on the LM-II
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AD
Mild Alzheimer's disease; meet NINCDS/ADRDA criteria for probable AD with mild dementia severity (CDR Total = 1), MMSE 20-26
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Reisa Sperling, MD, Director of Clinical Research, Memory Disorders Unit, Brigham and Women's Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Sperling R, Greve D, Dale A, Killiany R, Holmes J, Rosas HD, Cocchiarella A, Firth P, Rosen B, Lake S, Lange N, Routledge C, Albert M. Functional MRI detection of pharmacologically induced memory impairment. Proc Natl Acad Sci U S A. 2002 Jan 8;99(1):455-60. doi: 10.1073/pnas.012467899. Epub 2001 Dec 26.
- Sperling RA, Bates JF, Chua EF, Cocchiarella AJ, Rentz DM, Rosen BR, Schacter DL, Albert MS. fMRI studies of associative encoding in young and elderly controls and mild Alzheimer's disease. J Neurol Neurosurg Psychiatry. 2003 Jan;74(1):44-50. doi: 10.1136/jnnp.74.1.44.
- Greicius MD, Srivastava G, Reiss AL, Menon V. Default-mode network activity distinguishes Alzheimer's disease from healthy aging: evidence from functional MRI. Proc Natl Acad Sci U S A. 2004 Mar 30;101(13):4637-42. doi: 10.1073/pnas.0308627101. Epub 2004 Mar 15.
- Grundman M, Petersen RC, Ferris SH, Thomas RG, Aisen PS, Bennett DA, Foster NL, Jack CR Jr, Galasko DR, Doody R, Kaye J, Sano M, Mohs R, Gauthier S, Kim HT, Jin S, Schultz AN, Schafer K, Mulnard R, van Dyck CH, Mintzer J, Zamrini EY, Cahn-Weiner D, Thal LJ; Alzheimer's Disease Cooperative Study. Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials. Arch Neurol. 2004 Jan;61(1):59-66. doi: 10.1001/archneur.61.1.59.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IA0159
- 5R01AG027435-04 (Subvención/contrato del NIH de EE. UU.)
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