Brain Vascular Disease in Aging and Dementia

NCT03075007 | Completed

• 2 other identifiers: AAAR14232R56AG034189-06A1
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; White Matter Hyperintensities; Dementia; Aging

Keywords

Alzheimer Disease; Aging; Dementia; PET

Outcome Measures

Primary Outcomes (2)

• PET amyloid Standard Uptake Value ratio (SUVr) values

  The primary outcome is the mean standard uptake value ratio in the 4 regions of interest.

  up to 18 months

• Transcranial Doppler (TCD) dynamic autoregulatory dysfunction

  Cerebral blood flow velocities (CBFV) are assessed using TCD. Arterial blood pressure (ABP) is recorded simultaneously using the Finapres on the middle phalanx of the left or right middle finger. The phase shift between the two streaming signals is an indication of the extent to which oscillations in CBFV lead those in ABP and can be interpreted as active early counter-regulation. Lower phase shift reflects increased latency in cerebral vasomotion and thus poorer autoregulation.

  up to 18 months

Study Arms (1)

Group A

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

Radiation: Florbetaben F18; Procedure: Transcranial Doppler

Interventions

Florbetaben F18 RADIATION

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

Group A

Transcranial Doppler 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.

Group A

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants are recruited from a list of active members in the Washington Heights/Hamilton Heights/ Inwood Columbia Aging Project, known as WHICAP (CU IRB# AAAO9804), who previously completed a repeat MRI as part of a neuroimaging sub-study (IRB# AAAO9758). Some participants (n=30) will already have had baseline amyloid PET imaging under PI IRB protocol # 7130R (BAY 949172PET/CT in Older Adults).

You may qualify if:

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

You may not qualify if:

• allergic to Florbetaben
• claustrophobic
• liver problems
• history of epilepsy/seizures
• pre-menopausal
• serious medical conditions

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene; Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Adam M Brickman, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neuropsychology

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 9, 2017
• Study Start: May 23, 2017
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)