Alzheimer's DiseaseNCT01867372
Early Markers of Alzheimer's Disease: Structural and Functional Brain Changes
An observational study of Alzheimer's Disease, run by National Institute on Aging (NIA) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 213 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Mar 2003to 22 Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BLSA participants who do not meet exclusion criteria
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Kennedy Krieger Institute
Baltimore, Maryland, 21205
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
About this study
Official title: Early Markers of Alzheimer's Disease in BLSA Participants: Structural and Functional Brain Changes
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.
Read more
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.
Read the detailed description
We are examining changes in brain structure and function as predictors of cognitive decline and impairment through longitudinal neuroimaging assessments of selected Baltimore Longitudinal Study of Aging (BLSA) participants. The hypothesis driving this study is that accelerated preclinical changes in brain structure and function in specific regions, including mesial temporal cortex, cingulate cortex, and inferior parietal cortex, will predict which individuals subsequently develop cognitive impairment and Alzheimer s disease. Since 1994, magnetic resonance imaging (MRI), positron emission tomography (PET), and neuropsychological testing have been performed for the neuroimaging participants, aged 55 and older. In the next phase of this study, we will continue longitudinal testing of older participants and will continue enrolling additional participants. We will continue MRI studies of brain structure, with enhanced measures of vascular changes, and will perform PET studies of cerebral blood flow, amyloid distribution in brain, and, in a subset of participants, cerebral glucose metabolism. We will also extend the MRI and neuropsychological evaluations to an additional 60 BLSA participants aged 20 to 54. Our initial data indicate substantial changes in brain volumes and tissue composition through the 5th evaluation, despite only minimal cognitive change in this generally healthy sample. We will continue to follow these individuals and will examine modifiers of both structural and functional brain changes and their associations with cognitive decline. Potential modulators include genetic factors, hormonal status and therapies, medications, dietary supplements, and other health-related factors. We have already observed acceleration of hippocampal volume loss in individuals at increased genetic risk for Alzheimer s disease, carriers of the apolipoprotein E epsilon 4 allele, and modulation of memory and regional cerebral blood flow activation patterns as a function of postmenopausal hormone therapy in women and endogenous testosterone concentrations in men. We will continue to examine these and other modifiers of brain-behavior associations. Early prediction of cognitive impairment and factors that alter the incidence or progression of disease will be essential as new therapies are on the horizon.
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerated preclinical changes in brain structure and function in specific regions will predict which individuals develop cognitive impairment and Alzheimer s disease
Measured: Ongoing
Changes in brain structure are predictors of cognitive decline and impairment though neuroimaging assessments
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study start10 Mar 2003
- Primary completion22 Sep 2014
- Study completion22 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Susan M Resnick, Ph.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867372
- Sponsor's protocol ID
- 999903328
- Other IDs
- 03-AG-N328
- Status last verified
- 22 Sep 2014
- First submitted
- 30 May 2013
- Last updated
- 12 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Markers of Alzheimer's Disease in BLSA Participants: Structural and Functional Brain Changes
- ClinicalTrials.gov ID
- NCT01867372
- Acronym / sponsor ID
- 999903328
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 213 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Study start
- 10 Mar 2003
- Primary completion
- 22 Sep 2014 (actual)
- Study completion
- 22 Sep 2014
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We are examining changes in brain structure and function as predictors of cognitive decline and impairment through longitudinal neuroimaging assessments of selected Baltimore Longitudinal Study of Aging (BLSA) participants. The hypothesis driving this study is that accelerated preclinical changes in brain structure and function in specific regions, including mesial temporal cortex, cingulate cortex, and inferior parietal cortex, will predict which individuals subsequently develop cognitive impairment and Alzheimer s disease. Since 1994, magnetic resonance imaging (MRI), positron emission tomography (PET), and neuropsychological testing have been performed for the neuroimaging participants, aged 55 and older. In the next phase of this study, we will continue longitudinal testing of older participants and will continue enrolling additional participants. We will continue MRI studies of brain structure, with enhanced measures of vascular changes, and will perform PET studies of cerebral blood flow, amyloid distribution in brain, and, in a subset of participants, cerebral glucose metabolism. We will also extend the MRI and neuropsychological evaluations to an additional 60 BLSA participants aged 20 to 54. Our initial data indicate substantial changes in brain volumes and tissue composition through the 5th evaluation, despite only minimal cognitive change in this generally healthy sample. We will continue to follow these individuals and will examine modifiers of both structural and functional brain changes and their associations with cognitive decline. Potential modulators include genetic factors, hormonal status and therapies, medications, dietary supplements, and other health-related factors. We have already observed acceleration of hippocampal volume loss in individuals at increased genetic risk for Alzheimer s disease, carriers of the apolipoprotein E epsilon 4 allele, and modulation of memory and regional cerebral blood flow activation patterns as a function of postmenopausal hormone therapy in women and endogenous testosterone concentrations in men. We will continue to examine these and other modifiers of brain-behavior associations. Early prediction of cognitive impairment and factors that alter the incidence or progression of disease will be essential as new therapies are on the horizon.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BLSA participants who do not meet exclusion criteria
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accelerated preclinical changes in brain structure and function in specific regions will predict which individuals develop cognitive impairment and Alzheimer s disease
Time frame: Ongoing
Changes in brain structure are predictors of cognitive decline and impairment though neuroimaging assessments
Time frame: Ongoing
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan M Resnick, Ph.D. principal investigator
National Institute on Aging (NIA)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by National Institute on Aging (NIA) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerated preclinical changes in brain structure and function in specific regions will predict which individuals develop cognitive impairment and Alzheimer s disease (time frame: Ongoing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.