AgingNCT07099053
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
An observational study of Aging, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to 12 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women over age 55.
Who may be able to join
- 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 them 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
Luigi Ferrucci, M.D., 410-558-8110, ferruccilu@grc.nia.nih.gov
About this study
Official title: Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
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.
Read more
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.
Read the detailed description
Abstract
We are examining changes in brain structure, function, and neuropathology as predictors of cognitive decline and impairment through longitudinal neuroimaging assessments of selected Baltimore Longitudinal Study of Aging (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 parietal cortex, will predict which individuals subsequently develop cognitive impairment and Alzheimer s disease. Since 2005, we have 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. Through the protocol we are continuing longitudinal amyloid 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 (trade name Neuraceq TM) to measure in vivo amyloid distribution in individuals aged 55 years and older. 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 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 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 pathology in nondemented men and women throughout adulthood?
- What is the frequency and progression of brain amyloid 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 accumulation?
- What factors modulate cognitive and brain aging and how do they impact the relation between amyloid pathology and cognitive outcomes?
- How well do blood-based biomarkers of Alzheimer s disease, collected through the main BLSA study, reflect amyloid pathology in the brain?
- Conditions
- Aging
- Keywords
- Amyloid, PET
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults aged 55 and older. | Adults aged 55 and older. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amyloid accumulation
yearly PET scans
Measured: longitudinal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start28 Oct 2026 (estimated)
- Primary completion12 Dec 2029 (estimated)
- Study completion12 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Luigi Ferrucci, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099053
- Sponsor's protocol ID
- 10002099
- Other IDs
- 002099-AG
- Status last verified
- 30 Mar 2026
- First submitted
- 31 Jul 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No