Brain Vascular Disease in Aging and Dementia

NCT ID: NCT03075007

Last Updated: 2019-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-23

Study Completion Date

2019-08-31

Brief Summary

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This study examines the factors that may drive the relationship between vascular disease and Alzheimer's Disease (AD) in a large, longitudinal, multi-ethnic community-based cohort study of older adults in northern Manhattan, New York. In past research, the investigators demonstrated that accumulation of brain vascular disease is associated with risk for development of AD. The study now extends the research to examine how brain vascular disease and AD interact. In this pilot study, the investigators will obtain positron emission tomography (PET) scans to measure amyloid (one of the protein pathological markers of AD) from participants in an ongoing community-based study of aging and dementia (WHICAP). The study will include subjects who are already enrolled in the parent project. Further, this study will enroll both subjects who have never been evaluated with PET scans and those who received a previous baseline PET scan. The study plans to obtain approximately 30 repeat amyloid PET scans and 20 baseline PET scans. The investigators will also conduct transcranial Doppler studies to measure blood flow in the participants with amyloid PET scans. The potential benefits to society should be considerable if this study reveals new information about risk factors for or contributions to AD.

Detailed Description

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Alzheimer's disease (AD) is one of the most devastating international public health epidemics. There are currently no effective disease-modifying or preventative strategies. Current pathogenic models emphasize a single pathway of disease pathogenesis, but underestimate the contribution of small vessel cerebrovascular disease, which manifests primarily as white matter hyperintensities (WMH) on T2-weighted magnetic resonance imaging (MRI). Understanding of the factors that drive the relationship between vascular disease and AD remains elusive; vascular factors may be independent sources of dysfunction that contribute additively to clinical expression, they may interact mechanistically with AD pathology, and/or they may relate to each other because of a shared association with a third set of factors. These issues are particularly relevant among ethnic/racial minorities, who are at much greater risk for clinical AD, have more severe cerebrovascular disease, but appear to have similar levels of AD pathology compared with Whites.

The proposed research examines these factors in a large, longitudinal, multi-ethnic community-based cohort study of older adults in northern Manhattan, New York. The investigators demonstrated that accumulation of WMH, particularly in parietal lobes, predicts incident AD, and is associated with the presence of cerebral microbleeds, an indicator of cerebral amyloid angiopathy. The investigators extend the research to examine mechanistic interactions between cerebrovascular disease and AD. The preliminary data suggest that individuals with evidence of fibrillar amyloidosis have increased parietal lobe WMH and that hemodynamic markers of autoregulatory dysfunction are associated with both WMH and amyloid deposition, which in turn interact to promote the clinical expression of AD. These findings are buffered by new data that establish WMH as a core feature in autosomal dominant forms of AD. In this pilot study, the investigators propose to obtain cross-sectional and longitudinal MRI and amyloid PET data from participants in WHICAP.

Conditions

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Alzheimer Disease White Matter Hyperintensities Dementia Aging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

All participants will undergo an amyloid PET scan with Florbetaben F 18 contrast as well as a transcranial Doppler ultrasound.

Florbetaben F18

Intervention Type RADIATION

10Meq of Florbetaben F 18 via intravenous injection is to be used. Visit duration is approximately 3 hours.

Transcranial Doppler

Intervention Type PROCEDURE

All participants will undergo Doppler ultrasonography that measures the velocity of blood flow through the brain's blood vessels. Visit duration is approximately 45 minutes and will be scheduled for either the same day or another day as the PET scan.

Interventions

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Florbetaben F18

10Meq of Florbetaben F 18 via intravenous injection is to be used. Visit duration is approximately 3 hours.

Intervention Type RADIATION

Transcranial Doppler

All participants will undergo Doppler ultrasonography that measures the velocity of blood flow through the brain's blood vessels. Visit duration is approximately 45 minutes and will be scheduled for either the same day or another day as the PET scan.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* current participant in WHICAP (Washington Heights/Inwood Columbia Aging Project)
* subject previously participated in baseline MRI sub-study
* post-menopausal

Exclusion Criteria

* allergic to Florbetaben
* claustrophobic
* liver problems
* history of epilepsy/seizures
* pre-menopausal
* serious medical conditions
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Adam Brickman

Associate Professor of Neuropsychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam M Brickman, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2R56AG034189-06A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR1423

Identifier Type: -

Identifier Source: org_study_id

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