The Role of the Locus Coeruleus in Age-related Distractibility

Alzheimer Disease Clinical Trial

Official title:

Losing Specificity: the Role of the Locus Coeruleus in Age-related Distractibility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574634
• Other study ID #: 19-514
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2023
• Source: Virginia Polytechnic Institute and State University
• Contact: Tae-Ho Lee, PhD
• Phone: 540-231-6174
• Email: taehol[@]vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 dysconnectivity 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion:

• Healthy adult participants

• No younger than 18 and no older than 75 yrs of age

• Ability to provide written informed consent

Exclusion:

• History of surgery involving metal implants

• Possible metal fragments in the eyes

• Pacemaker

• A history of claustrophobia

• Braces

• Weighing over 250 pounds

• Pregnant or possibility of being pregnant.

• Severe medical or psychiatric conditions (e.g., blind or deaf, head trauma)

• Learning disabilities or developmental disabilities

Related Conditions & MeSH terms

• Aging
• Alzheimer Disease

Intervention

Behavioral:
• Tablet based adaptive multimodal attention practice program
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 program
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.

Locations

Country	Name	City	State
United States	Virginia Polytechnic Institute and State University	Blacksburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Scan before and after attentional practice (2 weeks between scans)
Primary	Change in fMRI LC-SN connectivity after two weeks	An fMRI measure of LC-SN connectivity	Scan before and after attentional practice (2 weeks between scans)