NCT01297114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

6.6 years

First QC Date

February 14, 2011

Last Update Submit

October 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognition as measured with cognitive evaluations

    We will assess the relationship between the presence of amyloid and cognition as measured with standard cognitive and neuropsychological tests

    cross sectional

Study Arms (2)

Participants aged 60-70

Participants age 60-70 will receive Florbetaben PET tracer to identify presence of amyloid burden.

Drug: Florbetaben

Participants aged 20-30

Younger participants will not undergo PET scanning that will be studied with other methods.

Interventions

This is a purely observational study. Results of the Florbetaben PET scan will be correlated with other observations.

Also known as: F-18 BAY
Participants aged 60-70

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

  • Oh H, Steffener J, Razlighi QR, Habeck C, Stern Y. beta-Amyloid Deposition Is Associated with Decreased Right Prefrontal Activation during Task Switching among Cognitively Normal Elderly. J Neurosci. 2016 Feb 10;36(6):1962-70. doi: 10.1523/JNEUROSCI.3266-15.2016.

    PMID: 26865619BACKGROUND
  • Oh H, Steffener J, Razlighi QR, Habeck C, Liu D, Gazes Y, Janicki S, Stern Y. Abeta-related hyperactivation in frontoparietal control regions in cognitively normal elderly. Neurobiol Aging. 2015 Dec;36(12):3247-3254. doi: 10.1016/j.neurobiolaging.2015.08.016. Epub 2015 Aug 24.

    PMID: 26382734BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood (frozen)

MeSH Terms

Conditions

Alzheimer Disease

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Yaakov Stern, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Neuropsychology

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 16, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

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

Locations