NCT07099053

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

April 21, 2026

Expected
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2029

Last Updated

April 16, 2026

Status Verified

March 30, 2026

Enrollment Period

3.6 years

First QC Date

July 31, 2025

Last Update Submit

April 15, 2026

Conditions

Keywords

AmyloidPET

Outcome Measures

Primary Outcomes (1)

  • Amyloid accumulation

    yearly PET scans

    longitudinal

Study Arms (1)

Adults aged 55 and older.

Adults aged 55 and older.

Eligibility Criteria

Age55 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men and women over age 55.

You may not qualify if:

  • 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.
  • 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.
  • 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.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Luigi Ferrucci, M.D.

    National Institute on Aging (NIA)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 1, 2025

Study Start (Estimated)

April 21, 2026

Primary Completion (Estimated)

December 12, 2029

Study Completion (Estimated)

December 12, 2029

Last Updated

April 16, 2026

Record last verified: 2026-03-30

Locations