Tracking amyloid in the aging brain with PET scans
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
PET scans will be used to track amyloid in people aged 55 and older enrolled in the Baltimore Longitudinal Study of Aging to see if amyloid changes are linked to memory decline or other brain changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 55 Years to 110 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07099053 on ClinicalTrials.gov |
What this trial studies
This longitudinal observational protocol performs serial PET imaging with the amyloid tracer (18F) florbetaben (Neuraceq) alongside routine BLSA MRI and cognitive testing to map amyloid distribution over time. Participants are BLSA volunteers aged 55 and older and receive imaging every 1 to 4 years, with annual scans for those 80 and older. About half of participants are also enrolled in an autopsy program to compare in vivo imaging with postmortem pathology. The goal is to link regional amyloid accumulation and other imaging measures to subsequent cognitive decline and resilience.
Who should consider this trial
Good fit: Ideal candidates are Baltimore Longitudinal Study of Aging participants aged 55 or older who can give informed consent, can undergo MRI, and do not have major central nervous system disease or excluded implants or conditions.
Not a fit: People with preexisting central nervous system diseases, implanted electronic hearing devices or pacemakers, certain active cancers, those exceeding the weight limit, or those not enrolled in the BLSA are unlikely to be eligible or to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could identify early amyloid changes that predict future cognitive decline, enabling earlier monitoring and targeted preventive strategies.
How similar studies have performed: Longitudinal amyloid PET using tracers such as PiB and florbetaben has been conducted since 2005 and has yielded important insights into amyloid accumulation, though it does not yet perfectly predict individual clinical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 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: * 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.
Where this trial is running
Baltimore, Maryland
- National Institute of Aging, Clinical Research Unit — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Luigi Ferrucci, M.D. — National Institute on Aging (NIA)
- Study coordinator: Wendy D Elkins
- Email: wendy.elkins@nih.gov
- Phone: (410) 558-8610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.