Alzheimer's DiseaseNCT01297114
Imaging of Cognition, Learning, and Memory in Aging
An observational study of Alzheimer's Disease, run by Yaakov Stern at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Florbetaben
- How many people
- 294 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to 1 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Aged 20-30 or 60-70
- Residing near Columbia University Medical Center
- Must be willing and able to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Florbetaben
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlorbetabenDrug
Also called F-18 BAY
This is a purely observational study. Results of the Florbetaben PET scan will be correlated with other observations.
| Study group | Role | What they receive |
|---|---|---|
| Participants aged 60-70 | Participants age 60-70 will receive Florbetaben PET tracer to identify presence of amyloid burden. Receives: Drug: Florbetaben | |
| Participants aged 20-30 | Younger participants will not undergo PET scanning that will be studied with other methods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: cross sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startMar 2011
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaakov Stern
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Yaakov Stern, Columbia University
- Investigators
- Yaakov Stern, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297114
- Sponsor's protocol ID
- AAAB0596
- Other IDs
- R01AG026158
- Status last verified
- Oct 2017
- First submitted
- 14 Feb 2011
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data could be shared based on NIH regulations
Publications
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.
PubMed 26865619Oh 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.
PubMed 26382734
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Cognition, Learning, and Memory in Aging
- ClinicalTrials.gov ID
- NCT01297114
- Acronym / sponsor ID
- AAAB0596
- Conditions
- Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Yaakov SternUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Mar 2011
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants aged 60-70 | – | Drug: FlorbetabenParticipants age 60-70 will receive Florbetaben PET tracer to identify presence of amyloid burden. |
| Participants aged 20-30 | – | –Younger participants will not undergo PET scanning that will be studied with other methods. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged 20-30 or 60-70
- Residing near Columbia University Medical Center
- Must be willing and able to participate
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlorbetabenAlso: F-18 BAYThis is a purely observational study. Results of the Florbetaben PET scan will be correlated with other observations. | Drug | Participants aged 60-70 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Background: PubMed 26865619Oh 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.
- Background: PubMed 26382734Oh 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.
- Individual participant dataSharing planned: Yes. De-identified data could be shared based on NIH regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaakov Stern, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Yaakov Stern at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition as measured with cognitive evaluations (time frame: cross sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01297114, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.