Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Brain Scan Study Tracks Aging and Memory Changes
Plain English Summary
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging is a Not Applicable clinical trial sponsored by National Institute on Aging (NIA) studying Aging. This study uses special brain scans to see how a protein called amyloid changes in the brain as people age. It is for individuals aged 55 and older who are already part of the Baltimore Longitudinal Study of Aging (BLSA). Participants will undergo brain scans and cognitive tests periodically over 5 years. The study aims to understand the link between amyloid buildup and changes in memory and thinking abilities. The trial aims to enroll 400 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You must be 55 years or older and already enrolled in the BLSA. You must be able to consent to participate. You cannot have certain pre-existing brain conditions like dementia, mild cognitive impairment, brain tumors, epilepsy, or Parkinson's disease. You also cannot have active metastatic cancer (except basal cell), certain types of cancer treatment history, or significant neurological issues like stroke or aneurysms. This trial is studying Aging, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how amyloid protein builds up in the brain over time, which could help researchers understand if this buildup is linked to changes in memory and thinking abilities as peop The specific primary outcome measures are: Amyloid accumulation (longitudinal). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it seeks to understand how amyloid, a protein that builds up in the brain, relates to cognitive decline during aging, potentially identifying early markers for age-rela This research targets Aging, where improved treatment options are needed.
Investor Insight
This observational study, sponsored by the National Institute on Aging, focuses on understanding aging-related brain changes, which is a critical area for future therapeutic development in neurodegene
Is This Trial Right for Me?
Ask your doctor if this study is right for you and how it relates to your current health. Participation involves regular visits for brain scans (PET CT) and cognitive tests, which may take up to 40 minutes. You will need to provide a contact person who can answer questions about your daily routine. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 400 participants
Primary Outcomes
- Amyloid accumulation (longitudinal)
Full Eligibility 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.
Trial Locations
- National Institute of Aging, Clinical Research Unit, Baltimore, Maryland, United States
Frequently Asked Questions
What is clinical trial NCT07099053?
NCT07099053 is a Not Applicable OBSERVATIONAL study titled "Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging." It is currently recruiting and is sponsored by National Institute on Aging (NIA). The trial targets enrollment of 400 participants.
What conditions does NCT07099053 study?
This trial investigates treatments for Aging. The primary condition under study is Aging.
What does Not Applicable mean for NCT07099053?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07099053?
This trial is currently "Recruiting." It started on 2026-04-05. The estimated completion date is 2029-12-12.
Who is sponsoring NCT07099053?
NCT07099053 is sponsored by National Institute on Aging (NIA). The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07099053?
The trial aims to enroll 400 participants. The trial is currently recruiting and accepting new participants.
How is NCT07099053 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07099053?
The primary outcome measures are: Amyloid accumulation (longitudinal). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07099053 being conducted?
This trial is being conducted at 1 site, including Baltimore, Maryland (United States).
Where can I find official information about NCT07099053?
The official record for NCT07099053 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07099053. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07099053 testing in simple terms?
This study uses special brain scans to see how a protein called amyloid changes in the brain as people age. It is for individuals aged 55 and older who are already part of the Baltimore Longitudinal Study of Aging (BLSA).
Why is this trial significant?
This trial is important because it seeks to understand how amyloid, a protein that builds up in the brain, relates to cognitive decline during aging, potentially identifying early markers for age-rela
What are the potential risks of participating in NCT07099053?
The PET CT scan involves a small injection of a tracer, which is generally safe but can have mild side effects like bruising at the injection site. Some participants may experience temporary discomfort during the scan due to lying still for 30 minutes. Cognitive tests are designed to assess memory and thinking, and results are for research purposes only. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07099053?
Ask your doctor if this study is right for you and how it relates to your current health. Participation involves regular visits for brain scans (PET CT) and cognitive tests, which may take up to 40 minutes. You will need to provide a contact person who can answer questions about your daily routine. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07099053 signal from an investment perspective?
This observational study, sponsored by the National Institute on Aging, focuses on understanding aging-related brain changes, which is a critical area for future therapeutic development in neurodegene This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will undergo brain scans and cognitive tests periodically over 5 years. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.