Imaging of Cognition, Learning, and Memory in Aging

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Columbia University
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yaakov Stern, Columbia University
ClinicalTrials.gov Identifier:
NCT01297114
First received: February 14, 2011
Last updated: August 24, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Alzheimer's Disease
Drug: Florbetaben

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Imaging of Cognition, Learning, and Memory in Aging

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Cognition as measured with cognitive evaluations [ Time Frame: cross sectional ] [ Designated as safety issue: No ]
    We will assess the relationship between the presence of amyloid and cognition as measured with standard cognitive and neuropsychological tests


Biospecimen Retention:   Samples With DNA
Whole blood (frozen)

Estimated Enrollment: 550
Study Start Date: March 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants aged 60-70
Participants age 60-70 will receive Florbetaben PET tracer to identify presence of amyloid burden.
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
Participants aged 20-30
Younger participants will not undergo PET scanning that will be studied with other methods.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297114

Contacts
Contact: Oksana Tatarina, MA 212-305-1987 ot2004@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Yaakov Stern, Ph.D.         
Sponsors and Collaborators
Yaakov Stern
National Institute on Aging (NIA)
Investigators
Principal Investigator: Yaakov Stern, PhD Columbia University
  More Information

Responsible Party: Yaakov Stern, Professor of Clinical Neurology, Aging and Dementia, Columbia University
ClinicalTrials.gov Identifier: NCT01297114     History of Changes
Other Study ID Numbers: AAAB0596  R01AG026158 
Study First Received: February 14, 2011
Last Updated: August 24, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: De-identified data could be shared based on NIH regulations

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 24, 2016