AgingNCT05574634
The Role of the Locus Coeruleus in Age-related Distractibility
A study testing Tablet based adaptive multimodal attention practice program and Tablet based adaptive criterion task practice program in people with Aging and Alzheimer Disease, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
A growing body of research has highlighted the importance of frontal regions, at both the functional and structural levels, in age-related declines in attentional and cognitive processing. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Alzheimer Disease
- What is being tested?
- Tablet based adaptive multimodal attention practice program and Tablet based adaptive criterion task practice program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult participants
- No younger than 18 and no older than 75 yrs of age
- Ability to provide written informed consent
Who cannot join
- History of surgery involving metal implants
- Possible metal fragments in the eyes
- Pacemaker
- A history of claustrophobia
- Braces
- Weighing over 250 pounds
Show all 9Show fewer
- Pregnant or possibility of being pregnant.
- Severe medical or psychiatric conditions (e.g., blind or deaf, head trauma)
- Learning disabilities or developmental disabilities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, 24061
Tae-Ho Lee, PhD, 540-231-6174, taehol@vt.edu
Benjamin Katz, PhD, 540-231-9816, katzben@vt.edu
About this study
Official title: Losing Specificity: the Role of the Locus Coeruleus in Age-related Distractibility
A growing body of research has highlighted the importance of frontal regions, at both the functional and structural levels, in age-related declines in attentional and cognitive processing. However, the underlying neurobiological pathophysiological changes in the brain that contribute to these declines are still largely unclear. The objective of this proposal is to investigate neural mechanisms of age-related attentional distractibility, focusing on the neural circuit initiated from the locus coeruleus (LC). In the current proposal, the investigators will test the hypothesis that the neural disconnectivity of LC with the salience network (SN) drives failures of ignoring distractors in older adults. The investigators will examine how LC-SN connectivity is associated with selective attention performance, and how improved LC-SN connectivity through a cognitive training program may lead to improved attentional performance.
- Conditions
- Aging, Alzheimer Disease
- Being tested
- Tablet based adaptive multimodal attention practice program, Tablet based adaptive criterion task practice program
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet based adaptive multimodal attention practice programBehavioural
An adaptive at-home tablet-based program that includes variants of the Flanker Task, the Stroop Task, and a Visual Tracking Task. Each session of practice will include up to ten minutes with each of these task types, and the tasks will increase in difficulty in a way that further taxes attention (such as through more distractors or more incongruent trials) as participant performance improves.
Tablet based adaptive criterion task practice programBehavioural
An adaptive, at-home tablet-based variant of the criterion task, that is, the selective attention/distraction task used during the scanning portion of the human participant portions of the study, that takes up to 25 minutes to complete each session.
| Study group | Role | What they receive |
|---|---|---|
| Older adult participants | Experimental | Older adult participants in the study will complete one of two variants of an attention practice program and that will be preceded by, and followed by, an fMRI scan session featuring an attention task Receives: Behavioral: Tablet based adaptive multimodal attention practice program; Behavioral: Tablet based adaptive criterion task practice program |
| Younger adult participants | No intervention | Younger adult participants in the study will complete one fMRI scan session featuring an attention task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in accuracy on the place-face selective attention task after two weeks
During this task, participants will be presented to with target place stimuli overlaid on nonexpressive faces) and be asked to identify categories of place images ('building' to 'house') selectively as soon as possible while ignoring overlapped faces. The investigators will also include place only images to measure participants' baseline neural activation when there is no distractor. Each image condition will be presented in a mixed event related design that includes 15 blocks for each condition as a function of image type (overlaid vs. place-only). The block order will be counterbalanced and each block will be separated by a 10-s blank screen.
Measured: Scan before and after attentional practice (2 weeks between scans)
Change in fMRI LC-SN connectivity after two weeks
An fMRI measure of LC-SN connectivity
Measured: Scan before and after attentional practice (2 weeks between scans)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start11 Apr 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tae-Ho Lee, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574634
- Sponsor's protocol ID
- 19-514
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Losing Specificity: the Role of the Locus Coeruleus in Age-related Distractibility
- ClinicalTrials.gov ID
- NCT05574634
- Acronym / sponsor ID
- 19-514
- Conditions
- Aging, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Oct 2022 (actual)
- 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.
A growing body of research has highlighted the importance of frontal regions, at both the functional and structural levels, in age-related declines in attentional and cognitive processing. However, the underlying neurobiological pathophysiological changes in the brain that contribute to these declines are still largely unclear. The objective of this proposal is to investigate neural mechanisms of age-related attentional distractibility, focusing on the neural circuit initiated from the locus coeruleus (LC). In the current proposal, the investigators will test the hypothesis that the neural disconnectivity of LC with the salience network (SN) drives failures of ignoring distractors in older adults. The investigators will examine how LC-SN connectivity is associated with selective attention performance, and how improved LC-SN connectivity through a cognitive training program may lead to improved attentional performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older adult participants | Experimental | Behavioral: Tablet based adaptive multimodal attention practice program, Behavioral: Tablet based adaptive criterion task practice programOlder adult participants in the study will complete one of two variants of an attention practice program and that will be preceded by, and followed by, an fMRI scan session featuring an attention task |
| Younger adult participants | No intervention | –Younger adult participants in the study will complete one fMRI scan session featuring an attention task |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult participants
- No younger than 18 and no older than 75 yrs of age
- Ability to provide written informed consent
Key exclusion criteria (9 listed)
- History of surgery involving metal implants
- Possible metal fragments in the eyes
- Pacemaker
- A history of claustrophobia
- Braces
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 |
|---|---|---|
| Tablet based adaptive multimodal attention practice programAn adaptive at-home tablet-based program that includes variants of the Flanker Task, the Stroop Task, and a Visual Tracking Task. Each session of practice will include up to ten minutes with each of these task types, and the tasks will increase in difficulty in a way that further taxes attention (such as through more distractors or more incongruent trials) as participant performance improves. | Behavioural | Older adult participants |
| Tablet based adaptive criterion task practice programAn adaptive, at-home tablet-based variant of the criterion task, that is, the selective attention/distraction task used during the scanning portion of the human participant portions of the study, that takes up to 25 minutes to complete each session. | Behavioural | Older adult participants |
Primary outcome
Change in accuracy on the place-face selective attention task after two weeks
Time frame: Scan before and after attentional practice (2 weeks between scans)
During this task, participants will be presented to with target place stimuli overlaid on nonexpressive faces) and be asked to identify categories of place images ('building' to 'house') selectively as soon as possible while ignoring overlapped faces. The investigators will also include place only images to measure participants' baseline neural activation when there is no distractor. Each image condition will be presented in a mixed event related design that includes 15 blocks for each condition as a function of image type (overlaid vs. place-only). The block order will be counterbalanced and each block will be separated by a 10-s blank screen.
Change in fMRI LC-SN connectivity after two weeks
Time frame: Scan before and after attentional practice (2 weeks between scans)
An fMRI measure of LC-SN connectivity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Tae-Ho Lee, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet based adaptive multimodal attention practice program and Tablet based adaptive criterion task practice program in people with Aging and Alzheimer Disease, run by Virginia Polytechnic Institute and State University 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 9 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tae-Ho Lee, PhD (540-231-6174, taehol@vt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in accuracy on the place-face selective attention task after two weeks (time frame: Scan before and after attentional practice (2 weeks between scans)). The study lists 2 primary outcomes in all. 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 14 Sep 2026.