NCT01867372

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

57
Monitor

Trial Health Score

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

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2003

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2014

Completed
Last Updated

December 12, 2019

Status Verified

September 22, 2014

Enrollment Period

11.5 years

First QC Date

May 30, 2013

Last Update Submit

December 11, 2019

Conditions

Keywords

Alzheimer's Disease

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

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Susan M Resnick, Ph.D.

    National Institute on Aging (NIA)

    PRINCIPAL INVESTIGATOR

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

Locations