Age-related Cognitive DeclineNCT01120860
Magnetic Resonance Imaging (MRI) and Decline of Aging Aviator Performance
An observational study of Age-related Cognitive Decline, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
The primary purpose of this study is to apply state-of-the-art Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopic Imaging (MRSI) techniques to measure changes over time in the brain. Read more about this study
- Who is it for?
- Ages 45 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Cognitive Decline
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Jul 2011
- 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 45 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: active healthy pilots
Who may be able to join
- Subjects will be included if they have participated in the protocol "Age-Related Longitudinal Changes in Aviator Performance" and agree to participate in this protocol.
Who cannot join
- Subjects will be excluded if they currently have a major neurological disease, unstable/untreated medical disease (such as untreated hypertension).
- In consideration of the magnetic fields in which subjects will be placed for the MR scanning, we will also exclude subjects who are unable to safely and comfortably complete the scanning session. This includes individuals who are wearing any metal prosthesis or who have cardiac pacemakers or any other nonremovable metal objects.
- Subjects reporting a history of severe claustrophobia or poorly controlled back pain will be excluded because it is unlikely they could comfortably remain still in the MRI scanner for the duration of the scan.
- In addition, subjects who do not fit in the apparatus will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Official title: MRI and Decline of Aging Aviator Performance
The primary purpose of this study is to apply state-of-the-art Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopic Imaging (MRSI) techniques to measure changes over time in the brain.
Read the detailed description
We expect that MRI and MRSI techniques will be a useful adjunct in research efforts to understand individual differences in performance of a complex attention-demanding task, such as flying a plane or driving a car. Other predictors of change in performance of a complex task may include simple tests of processing speed and working memory, past training and recent practice of the task, and genetic risk factors for degenerative brain disease. In this project, we will examine whether baseline MR measures are as useful as longitudinal MR measures in predicting amount of change over time in task performance.
This research is part of a long-term effort to achieve earlier identification of individuals at risk of decline and ultimately minimize loss of function.
- Conditions
- Age-related Cognitive Decline
- Being tested
- MRI
- Keywords
- Cognitive Aging, Apolipoproteins E, Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MRI - routine imaging sequences, designed for anatomical quantification
What is being measured
The primary outcome is the main question the study is designed to answer.
flight simulator performance summary score
z-score composite of executing ATC communications, avoiding traffic, monitoring engine malfunctions, visual approach and landing
Measured: yearly for up to 6 years
Secondary outcomes (2)
CogScreen-AE
computerized battery (assesses processing speed, executive function, paired assoc memory, n-back task, psychomotor tracking
Measured: yearly
Salthouse processing speed measures
digit copy \& pattern comparison
Measured: yearl
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startNov 2002
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Cognitive DeclineStudies 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
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joy Taylor, Stanford University
- Investigators
- Joy Taylor, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120860
- Sponsor's protocol ID
- TAYRNW0001/TAY0002
- Other IDs
- 11097
- Status last verified
- Feb 2017
- First submitted
- 7 May 2010
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI and Decline of Aging Aviator Performance
- ClinicalTrials.gov ID
- NCT01120860
- Acronym / sponsor ID
- TAYRNW0001/TAY0002
- Conditions
- Age-related Cognitive Decline
- Keywords
- Cognitive Aging, Apolipoproteins E, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 May 2010 (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.
The primary purpose of this study is to apply state-of-the-art Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopic Imaging (MRSI) techniques to measure changes over time in the brain.
Detailed description
We expect that MRI and MRSI techniques will be a useful adjunct in research efforts to understand individual differences in performance of a complex attention-demanding task, such as flying a plane or driving a car. Other predictors of change in performance of a complex task may include simple tests of processing speed and working memory, past training and recent practice of the task, and genetic risk factors for degenerative brain disease. In this project, we will examine whether baseline MR measures are as useful as longitudinal MR measures in predicting amount of change over time in task performance.
This research is part of a long-term effort to achieve earlier identification of individuals at risk of decline and ultimately minimize loss of function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- active healthy pilots
Key inclusion criteria (1 listed)
- Subjects will be included if they have participated in the protocol "Age-Related Longitudinal Changes in Aviator Performance" and agree to participate in this protocol.
Key exclusion criteria (4 listed)
- Subjects will be excluded if they currently have a major neurological disease, unstable/untreated medical disease (such as untreated hypertension).
- In consideration of the magnetic fields in which subjects will be placed for the MR scanning, we will also exclude subjects who are unable to safely and comfortably complete the scanning session. This includes individuals who are wearing any metal prosthesis or who have cardiac pacemakers or any other nonremovable metal objects.
- Subjects reporting a history of severe claustrophobia or poorly controlled back pain will be excluded because it is unlikely they could comfortably remain still in the MRI scanner for the duration of the scan.
- In addition, subjects who do not fit in the apparatus will also be excluded.
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 |
|---|---|---|
| MRIMRI - routine imaging sequences, designed for anatomical quantification | Device | – |
Primary outcome
flight simulator performance summary score
Time frame: yearly for up to 6 years
z-score composite of executing ATC communications, avoiding traffic, monitoring engine malfunctions, visual approach and landing
2 secondary outcomes
CogScreen-AE
Time frame: yearly
Salthouse processing speed measures
Time frame: yearl
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 28 Feb 2017.
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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.
Joy Taylor principal investigator
Stanford 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 Age-related Cognitive Decline, run by Palo Alto Veterans Institute for Research 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 1 inclusion and 4 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 28 Feb 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?
flight simulator performance summary score (time frame: yearly for up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2017.