Early Markers of Alzheimer's Disease: Structural and Functional Brain Changes
2 other identifiers
observational
213
1 country
3
Brief Summary
Background: \- Participants in the Baltimore Longitudinal Study of Aging are being studied to examine changes in brain structure and function over time, and to determine if these changes can predict the likelihood that an individual will develop thinking and memory impairments such as Alzheimer s disease later in life. Imaging studies and neuropsychological testing have been conducted on current participants, and new participants are being recruited to the study. To develop better treatments and therapies for aging-related memory loss and other disorders, researchers are interested in determining whether early prediction of thinking and memory impairments are accurate and in evaluating factors that affect these predictions. Objectives: \- To use imaging studies and tests of thinking and memory to determine early markers of Alzheimer s disease and other cognitive impairments. Eligibility: \- Current participants and new recruits to the Baltimore Longitudinal Study of Aging. Design:
- Participants will be screened with a full medical history and physical examination, as well as blood and urine tests.
- Participants will have testing visits as directed by the study researchers. All participants will have tests as part of their an initial enrollment in the study, and may be asked to return yearly, 2 years later, or 4 years later for repeated tests.
- At each visit, participants will have brain imaging scans (including magnetic resonance imaging and/or magnetic resonance spectroscopy to measure brain structure and function, and positron emission tomography to study blood flow in the brain) to evaluate brain structure and function. Participants will also take tests of memory and problem-solving skills.
- Treatment will not be provided as part of this protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2003
Longer than P75 for all trials
3 active sites
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
Study Start
First participant enrolled
March 10, 2003
CompletedFirst Submitted
Initial submission to the registry
May 30, 2013
CompletedFirst Posted
Study publicly available on registry
June 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2014
CompletedDecember 12, 2019
September 22, 2014
11.5 years
May 30, 2013
December 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Accelerated preclinical changes in brain structure and function in specific regions will predict which individuals develop cognitive impairment and Alzheimer s disease
Ongoing
Changes in brain structure are predictors of cognitive decline and impairment though neuroimaging assessments
Ongoing
Eligibility Criteria
You may not qualify if:
- Miscellaneous: Body weight \> 300 pounds, history of significant radiation exposure.
- Participants with pacemakers, implanted electronic hearing devices, aneurysm clips, shrapnel, unallowed prosthetic or any other metallic device in their bodies.
- Pre-existing CNS disease or severe cardiovascular disease (MI, CABG, angioplasty).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute on Aging (NIA)lead
- Johns Hopkins Universitycollaborator
Study Sites (3)
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Kennedy Krieger Institute
Baltimore, Maryland, 21205, United States
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan M Resnick, Ph.D.
National Institute on Aging (NIA)
Study Design
- Study Type
- observational
- Time Perspective
- OTHER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2013
First Posted
June 4, 2013
Study Start
March 10, 2003
Primary Completion
September 22, 2014
Study Completion
September 22, 2014
Last Updated
December 12, 2019
Record last verified: 2014-09-22