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RecruitingNCT07099053Updated Nov 10, 2026

PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)

An observational study in Aging, sponsored by National Institute on Aging (NIA). Recruiting at 1 site in United States. Open to participants aged 55 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by National Institute on Aging (NIA) · Observational

Updated Nov 10, 2026Start date movedEligibility revised+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
400
Ages
55 Years to 110 Years
Sex
All
01

Study 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. 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.

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?
02

Conditions studied

  • Aging

Browse trials for

Keywords

  • Amyloid
  • PET
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

National Institute on Aging (NIA) is the lead sponsor of 160 studies on the registry; 13 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 2, 2026. See what changed

Ages eligible
55 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Men and women over age 55.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion 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

EXCLUSION CRITERIA:

  • Preexisting central nervous system diseases
  • Weight over 300 lbs.
  • Active 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
400 participants (estimated)

Groups and cohorts

  • Adults aged 55 and older.

    Adults aged 55 and older.

06

What researchers measure

Primary outcomes

  1. Amyloid accumulation

    yearly PET scans

    Time frame: longitudinal

07

Study locations

1 of 1 sites recruiting
08

Updates

32 registry updates since Sep 25, 2026
Start date
Sep 29, 2026→Nov 15, 2026
moved 32 times, Sep 25, 2026 – Nov 10, 2026
Eligibility
2 inclusion criteria edited; 1 exclusion criterion added
What changed in the criteria
Inclusion criteria
  • EditedInclusion criteria:. BLSA participants who do not meet exclusion criteria and have had or agreed to have an MRI under the BLSA study.
  • EditedParticipants 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.
Exclusion criteria
  • AddedParticipants undergoing chronic treatment with a CYP1A2 inducer will be ineligible for Tauklarify PET, but this does not constitute an exclusion criterion for Neuraceq PET.
Nov 2, 2026
Title
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Nov 2, 2026
Show all 32 updates
  1. Nov 10, 2026
    Start date Nov 12, 2026→Nov 15, 2026
    + 1 other change: description
  2. Nov 9, 2026
    Start date Nov 11, 2026→Nov 12, 2026
  3. Nov 6, 2026
    Start date Nov 10, 2026→Nov 11, 2026
  4. Nov 5, 2026
    Start date Nov 9, 2026→Nov 10, 2026
  5. Nov 4, 2026
    Start date Nov 8, 2026→Nov 9, 2026
  6. Nov 3, 2026
    Start date Nov 5, 2026→Nov 8, 2026
    + 1 other change: description
  7. Nov 2, 2026
    Start date Nov 4, 2026→Nov 5, 2026
    Eligibility 2 inclusion criteria edited; 1 exclusion criterion added
    What changed in the criteria
    Inclusion criteria
    • EditedInclusion criteria:. BLSA participants who do not meet exclusion criteria and have had or agreed to have an MRI under the BLSA study.
    • EditedParticipants 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.
    Exclusion criteria
    • AddedParticipants undergoing chronic treatment with a CYP1A2 inducer will be ineligible for Tauklarify PET, but this does not constitute an exclusion criterion for Neuraceq PET.
    Title Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
    + 2 other changes: verification date and description
  8. Oct 30, 2026
    Start date Nov 3, 2026→Nov 4, 2026
  9. Oct 29, 2026
    Start date Nov 2, 2026→Nov 3, 2026
    + 1 other change: description
  10. Oct 28, 2026
    Start date Nov 1, 2026→Nov 2, 2026
  11. Oct 27, 2026
    Start date Oct 29, 2026→Nov 1, 2026
  12. Oct 26, 2026
    Start date Oct 28, 2026→Oct 29, 2026
    + 1 other change: description
  13. Oct 23, 2026
    Start date Oct 27, 2026→Oct 28, 2026
  14. Oct 22, 2026
    Start date Oct 26, 2026→Oct 27, 2026
  15. Oct 21, 2026
    Start date Oct 25, 2026→Oct 26, 2026
  16. Oct 20, 2026
    Start date Oct 22, 2026→Oct 25, 2026
  17. Oct 19, 2026
    Start date Oct 21, 2026→Oct 22, 2026
  18. Oct 16, 2026
    Start date Oct 20, 2026→Oct 21, 2026
  19. Oct 15, 2026
    Start date Oct 19, 2026→Oct 20, 2026
  20. Oct 14, 2026
    Start date Oct 18, 2026→Oct 19, 2026
  21. Oct 13, 2026
    Start date Oct 14, 2026→Oct 18, 2026
  22. Oct 9, 2026
    Start date Oct 13, 2026→Oct 14, 2026
  23. Oct 8, 2026
    Start date Oct 12, 2026→Oct 13, 2026
    + 1 other change: description
  24. Oct 7, 2026
    Start date Oct 11, 2026→Oct 12, 2026
  25. Oct 6, 2026
    Start date Oct 8, 2026→Oct 11, 2026
  26. Oct 5, 2026
    Start date Oct 7, 2026→Oct 8, 2026
  27. Oct 2, 2026
    Start date Oct 6, 2026→Oct 7, 2026
    + 1 other change: description
  28. Oct 1, 2026
    Start date Oct 5, 2026→Oct 6, 2026
  29. Sep 30, 2026
    Start date Oct 4, 2026→Oct 5, 2026
  30. Sep 29, 2026
    Start date Oct 1, 2026→Oct 4, 2026
  31. Sep 28, 2026
    Start date Sep 30, 2026→Oct 1, 2026
  32. Sep 25, 2026
    Start date Sep 29, 2026→Sep 30, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07099053
Responsible party
Sponsor
First posted
Aug 1, 2025
Start date
Nov 15, 2026 (estimated)
Primary completion
Dec 12, 2029 (estimated)
Completion
Dec 12, 2029 (estimated)
Last update
Nov 10, 2026

Study contacts

Wendy D Elkins
Contact
wendy.elkins@nih.gov
(410) 558-8610
Luigi Ferrucci, M.D.
Contact
ferruccilu@grc.nia.nih.gov
(410) 558-8110
Luigi Ferrucci, M.D.
principal investigator · National Institute on Aging (NIA)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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