AgingNCT07099053
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
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
- 11 Nov 2026to 12 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 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
Show all 27Show fewer
- 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.
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
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:
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?
- 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 start11 Nov 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
- 29 Oct 2026
- First submitted
- 31 Jul 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
- ClinicalTrials.gov ID
- NCT07099053
- Acronym / sponsor ID
- 10002099
- Conditions
- Aging
- Keywords
- Amyloid, PET
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- 12 Dec 2029 (estimated)
- Study completion
- 12 Dec 2029 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
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?
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults aged 55 and older. | – | –Adults aged 55 and older. |
Who may qualify
- Ages
- 55 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women over age 55.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amyloid accumulation
Time frame: longitudinal
yearly PET scans
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luigi Ferrucci, M.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy D Elkins ((410) 558-8610, wendy.elkins@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amyloid accumulation (time frame: longitudinal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.