PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
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
- 55 años - 110 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 400 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
Background:
Some people experience cognitive decline as they age. That is, they lose memory, problem-solving, and other mental abilities. Amyloids are groups of proteins that develop in the brain and increase in number as people age. Researchers want to use imaging scans to track amyloids in people s brains over time. Their goal is to find out if any changes are related to cognitive decline or other medical issues.
Objective:
To learn how amyloids may affect brain structure and function as people age.
Eligibility:
People aged 55 years and older who are enrolled in the Baltimore Longitudinal Study of Aging.
Design:
Participants will have imaging scans and other tests every 1 to 4 years, depending on their age. Those 80 and older will be scanned yearly. These scans will be done during regular BLSA visits.
The scans will be positron emission tomography and computed tomography (PET CT). Participants will be given fluid through a tube inserted into a vein in their arm. The fluid is a tracer that will cause the amyloids to light up in the images. Then they will lie on a bed with their head inside a PET CT scanner. They will lie still for about 30 minutes.
Participants will have tests to assess their memory and other mental skills. They will answer questions about their mood and daily life. These tests will take about 40 minutes to complete; they may be done in person or by phone.
Participants will give a contact number for someone who can answer questions about the participant s daily routine. These questions may be answered in person or by phone.
Participants will be in this study for 5 years.
Leer la descripción completa
Abstract:
This protocol continues and expands a longitudinal brain positron emission tomography (PET) imaging study that will support multiple hypothesis-driven investigations within the Baltimore Longitudinal Study of Aging (BLSA). We are examining changes in brain structure, function, and neuropathology as predictors of cognitive decline and impairment through longitudinal neuroimaging assessments of selected BLSA participants at the National Institute on Aging (NIA). The hypothesis driving this study is that accelerated preclinical changes in brain structure and function in specific regions, including mesial temporal cortex, cingulate cortex, precuneus, and inferior temporal and parietal cortex, will predict which individuals subsequently develop cognitive impairment and Alzheimer s disease (AD). Between 2005 and 2022, we performed serial positron emission tomography (PET) with the radiotracer (11C) Pittsburgh compound B (PiB) to measure amyloid pathology in a subset of participants from the BLSA to investigate the neuropathological basis of memory change and cognitive impairment. Additionally, between 2016 and 2022, we performed serial PET with the radiotracer (18F) flortaucipir (Tauvid (TM)) to measure neurofibrillary tau tangle pathology in a subset of the BLSA participants who undergo amyloid PET imaging. Through the current protocol we are continuing longitudinal amyloid and tau PET imaging of older participants and evaluating new participants. In conjunction with each BLSA visit, we will perform a single PET scan of (18F) florbetaben (Neuraceq (R)) to measure in vivo amyloid distribution in individuals aged 55 years and older. In addition, we will implement PET imaging of tau neurofibrillary tangles using \[18F\]florquinitau (Tauklarify (TM)) PET scans. In combination, PET imaging of amyloid and tau will provide in vivo imaging biomarkers of neuropathology. Such biomarkers have been implemented into research guidelines for definition of preclinical AD as well as incorporated into guidelines for diagnosis of mild cognitive impairment. Approximately half of the neuroimaging study participants are enrolled in the BLSA autopsy program, and the integration of autopsy and imaging findings is an active area of investigation to gain a better understanding of factors that promote cognitive resilience in individuals who have amyloid and tau pathology but do not show memory impairment. In addition, we are using neuroimaging tools to investigate modulators of cognitive and brain changes, including sex differences in brain aging, genetic risk factors, and the effects of sex steroid and other hormones. An understanding of these brain-behavior associations and early detection of accelerated brain changes that predict cognitive decline and impairment will be critical in identifying individuals likely to benefit from new interventions.
Objectives:
The principal goal of the project is the acquisition of longitudinal data on regional brain amyloid and tau levels in BLSA participants to investigate these changes in relation to other medical, brain imaging, psychological, and cognitive data collected through the BLSA. Specifically, the primary objectives are to continue to address the following questions:
- What are the rates and regional distribution of changes in brain amyloid and tau pathology in non-demented men and women throughout adulthood?
- What is the frequency and progression of brain amyloid and tau pathology in older adults and what is the clinical significance of these findings for cognitive aging?
- Against a background of age-related changes in brain structure and function, which changes predict cognitive impairment and dementia and when do these changes occur in relation to the onset of amyloid and tau accumulation?
- What factors modulate cognitive and brain aging and how do they impact the relation between amyloid and tau pathology and cognitive outcomes?
- How well do blood-based biomarkers of AD, collected through the main BLSA study, reflect amyloid and tau pathology in the brain?
¿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/EXCLUSION CRITERIA:
- Participants are men and women 55 years and older drawn from the BLSA sample and thus, represent the gender/ethnic characteristics of this study group. Enrollment is defined as the initial imaging session of the planned longitudinal study.
- Inclusion criteria. BLSA participants who do not meet exclusion criteria and have had or agreed to have an MRI under the BLSA study.
- Participants who lack capacity to consent will not be enrolled in the study. If the participant loses capacity to consent over the course of follow-up they will be removed from the study. Competency to consent is assessed as part of the BLSA visit and we will not include people who are not competent to provide consent.
EXCLUSION CRITERIA:
- Preexisting central nervous system diseases
- Weight over 300 lbs.
- Active metastatic cancer (except basal cell cancer)
- Implanted electronic hearing devices
- Breast Cancer with radiation treatment
- Lymphoma
- Pacemaker
- Brain tumor
- Shrapnel
- Schizophrenia
- Bipolar disorder
- Epilepsy
- Language barrier that makes it difficult to understand participant.
- Aneurisms greater than 3mm
- Aneurysm clips
- Parkinson s disease/PD medications
- Huntington s disease
- Severe Endocrinopathy- treated thyroid conditions ok; treated, controlled diabetes ok. (exclude HbA1c over 8 which is poorly controlled diabetes)
- Diagnosis of dementia or mild cognitive impairment
- Younger than 55 years of age
- Pregnancy
- Ineligible for MRI
- History of stroke or documented TIAs requiring hospitalization
- Known brain vascular malformations or adenomas
- History of significant radiation exposure
- Those with a Blessed score of 4 or more with the BLSA will be reviewed at a research diagnostic case conference to rule out dementia diagnoses prior to enrollment.
- Participants undergoing chronic treatment with a CYP1A2 inducer will be ineligible for Tauklarify PET, but this does not constitute an exclusion criterion for Neuraceq PET.
Población del estudio
Men and women over age 55.
Entiende la evaluación inicialTratamiento, 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
Adults aged 55 and older.
Adults aged 55 and older.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Amyloid accumulation
Plazo: longitudinal
yearly PET scans
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
National Institute of Aging, Clinical Research UnitBaltimore, Maryland, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- National Institute on Aging (NIA)
- Inicio del estudio
- 15 nov 2026 Estimado
- Finalización primaria
- 12 dic 2029 Estimado
- Finalización del estudio
- 12 dic 2029 Estimado
- Primera publicación
- 1 ago 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Consulta a Wellness Clinical Research
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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: 11 nov 2026 · Última actualización del registro: 10 nov 2026