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Imaging of Cognition, Learning, and Memory in Aging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01297114
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yaakov Stern, Columbia University

Tracking Information
First Submitted Date February 14, 2011
First Posted Date February 16, 2011
Last Update Posted Date November 1, 2017
Study Start Date March 2011
Actual Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 23, 2013)
Cognition as measured with cognitive evaluations [ Time Frame: cross sectional ]
We will assess the relationship between the presence of amyloid and cognition as measured with standard cognitive and neuropsychological tests
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Imaging of Cognition, Learning, and Memory in Aging
Official Title Imaging of Cognition, Learning, and Memory in Aging
Brief Summary This investigation is designed to study how the brain functions when it is performing explicit memory tasks, and furthermore how the brain systems supporting performance on these tests change as a function of aging. Implicit memory tasks may be distinguished from explicit memory tests in that explicit memory characterizes the directed or intentional recollection of previously learned information or events. In contrast, implicit (or nonconscious) memory is expressed in the facilitation of performance on some task or judgment on a stimulus owing to a prior presentation of that stimulus, without any necessary conscious awareness of the prior presentation. The investigators propose to use functional Magnetic resonance Imaging (fMRI) to measure brain activity during the performance of carefully designed explicit memory tasks. Comparison of brain activity during the different test conditions will provide information about the brain areas that are involved in mediating specific aspects of performance. Both older and younger individuals will be tested in order to understand age related changes in the brain activity. In order to examine the interactions between participants' differential levels of amyloid burden and their performance on cognitive tasks and fMRI neural activation, the investigators also propose PET imaging of older participants.
Detailed Description

The basic approach to measuring the brain activity associated with a given cognitive process (or processes) is as follows: It is known that increases in brain neuronal activity are associated with local increases in energy metabolism. Under normal circumstances, increases in brain metabolism lead to local changes in blood oxygenation in venules and larger veins. This change in blood oxygenation can be detected imaging methods which are sensitive to the differences in magnetic state between oxygenated and deoxygenated hemoglobin.

The ultimate benefit of this research is to better understand how changes in both performance and the brain organization underlying that performance are affected by aging.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood (frozen)
Sampling Method Probability Sample
Study Population Subjects will be recruited from ads placed in local newspapers and notices posted in the vicinity of Columbia University, the Columbia Presbyterian Medical Center, and in local senior centers that provide written consent for notice placement. We will also utilize a market mailing approach. Letters will be sent to appropriately aged potential subjects randomly selected from commercial lists. Additional elderly subjects will be recruited from the Sergievsky Joint Database. Informed consent will be elicited from all subjects.
Condition Alzheimer's Disease
Intervention Drug: Florbetaben
This is a purely observational study. Results of the Florbetaben PET scan will be correlated with other observations.
Other Name: F-18 BAY
Study Groups/Cohorts
  • Participants aged 60-70
    Participants age 60-70 will receive Florbetaben PET tracer to identify presence of amyloid burden.
    Intervention: Drug: Florbetaben
  • Participants aged 20-30
    Younger participants will not undergo PET scanning that will be studied with other methods.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 30, 2017)
294
Original Estimated Enrollment
 (submitted: February 15, 2011)
550
Actual Study Completion Date October 1, 2017
Actual Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Aged 20-30 or 60-70
  • Residing near Columbia University Medical Center
  • Must be willing and able to participate

Exclusion Criteria:

  • Have a contraindication to PET (e.g, metallic implants, pacemaker, claustrophobia, or cannot lie flat for one hour)
  • Pregnancy
  • Lactating Women
  • Current, past, or anticipated exposure to radiation
  • Significant active physical illness
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01297114
Other Study ID Numbers AAAB0596
R01AG026158 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: De-identified data could be shared based on NIH regulations
Time Frame: Study data will be available within 1 year
Access Criteria: We will be sharing de-identified data with a consortium that is aggregating studies that have employed amyloid PET tracers
Responsible Party Yaakov Stern, Columbia University
Study Sponsor Yaakov Stern
Collaborators National Institute on Aging (NIA)
Investigators
Principal Investigator: Yaakov Stern, PhD Columbia University
PRS Account Columbia University
Verification Date October 2017