Investigación local. Conexiones humanas. WCR Miami Lakes (786) 483-7856
Volver a buscar estudiosNCT05372172
ReclutandoNCT05372172Registro de ClinicalTrials.gov

Tennessee Alzheimer's Project

Aging · Alzheimer Disease · Biomarker · Cognitive Dysfunction · Mild Cognitive Impairment · Dementia · Cognition

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
60 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
1000 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The primary objective of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to provide local and national researchers with access to a well-characterized and diverse clinical cohort, including participant referrals, biosamples, clinical data, and neuroimaging data. The VADRC Clinical Core will create an infrastructure to support research efforts of both local and national investigator studies to develop early detection, prevention, and treatment strategies for Alzheimer's disease. The Clinical Core intends to enroll up to 1000 participants, including individuals who are cognitively unimpaired, have mild cognitive impairment, or have Alzheimer's disease. This cohort of about 1000 participants will be called the Tennessee Alzheimer's Project. Participants will be seen annually for comprehensive clinical characterization and then referred to other studies to enhance Alzheimer's disease research activities.

Leer la descripción completa

Alzheimer's disease (AD) is a growing public health crisis affecting 5.8 million Americans. With the aging population, AD prevalence is expected to double by 2040. Successful AD prevention and effective therapies require distilling complexities of the disease to better model disease onset, progression, and treatment response. The purpose of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to provide a better understanding of AD and related dementias, and to serve as the institutional hub of clinical, research, and educational initiatives in AD. The Center will play an essential role in expanding AD discoveries and reducing the burden of AD locally and nationally. To do so, the VADRC will support multiple human studies and model systems research over the coming years. For the Tennessee Alzheimer's Project, the team will establish, phenotype, and annually follow a cohort of adults age 60 and older with and without memory problems. Phenotyping will include standardized protocols implemented across the entire national ADRC network as part of the National Alzheimer's Coordinating Center as well as protocols specific to our local site, including (but not limited to) venous blood draw, questionnaires, physical examination, echocardiogram, neuropsychological assessment, multi-modal neuroimaging, and cerebrospinal fluid acquisition via lumbar puncture. As part of the Center's autopsy program, the investigators will ask all Tennessee Alzheimer's Project participants to consider post-mortem donation of their brain, eyes, and a small skin sample. While fluid and neuroimaging biomarkers exist for some neuropathologies associated with AD and related dementias, postmortem characterization is the only current way to definitively confirm the presence and severity of disease. Locally, a robust tissue bank with excellent ante-mortem phenotyping will provide invaluable tissue for analyses distilling the complexities of AD.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

  • Age 60 or older
  • Meet standard criteria for (a) cognitively unimpaired, (b) mild cognitive impairment, or (c) Alzheimer's disease
  • English speaking
  • Individuals who lack decisional capacity to provide informed consent at baseline will not be enrolled in the study

Exclusion Criteria:

  • No available reliable study partner (reliable is defined as someone who interacts significantly with the participant and is available to participate in study visits in person or by phone)
  • History of major psychiatric illness (e.g., schizophrenia, bipolar), neurological illness (e.g., epilepsy, multiple sclerosis, Parkinson's disease), or head injury with significant loss of consciousness.
  • Unable to undergo MRI (e.g., claustrophobia, ferrous metal in body)

Población del estudio

Community-dwelling older adults.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No informado
Enmascaramiento
No informado
Cognitively unimpaired

A consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines.

Other: none, observational study

Mild cognitive impairment

A consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines.

Other: none, observational study

Alzheimer's disease

A consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines.

Other: none, observational study

none, observational study OTHER

none, observational study

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Cognitive status

Plazo: baseline to year 3

Change in cognitive status assessed by the Uniform Dataset according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines determined by a consensus team.

APOE Genotype

Plazo: baseline to year 3

APOE e4 allele status

White matter hyperintensities Volume

Plazo: baseline to year three

White matter lesion volume measured by FLAIR imaging modality

Grey Matter Volume

Plazo: baseline to year three

Grey matter volume measured by T1 imaging modality

Cerebral Blood Flow

Plazo: baseline to year three

Resting cerebral blood flow to brain regions measured by T3 perfusion

Lacunar infarcts

Plazo: baseline to year three

Number of lacunar infarcts measured by MRI

Microbleeds

Plazo: baseline to year three

Number of microbleeds measured by MRI

Left ventricular ejection fraction

Plazo: baseline to year three

Left ventricular ejection fraction measured by echocardiogram

Cardiac output

Plazo: baseline to year three

Amount of blood the heart pumps from each ventricle per minute (litres per minute (L/min)), measured by echocardiogram

Stroke volume

Plazo: baseline to year three

Stroke volume measured by echocardiogram

Heart rate

Plazo: baseline to year three

Heart rate measured by echocardiogram

Biological markers for Alzheimer's disease

Plazo: baseline to year three

Tau, amyloid, and neurodegenerative levels in cerebrospinal fluid samples

Blood based biological marker for Alzheimer's disease

Plazo: baseline to year three

Tau, amyloid, and neurodegenerative levels in blood samples

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Vanderbilt University Medical CenterNashville, Tennessee, United StatesReclutando

Equipo y fechas

Patrocinador principal
Vanderbilt University Medical Center
Inicio del estudio
27 oct 2021 Real
Finalización primaria
31 mar 2030 Estimado
Finalización del estudio
31 mar 2030 Estimado
Primera publicación
12 may 2022 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Título oficial del estudio

Tennessee Alzheimer's Project

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026