Strategic Training to Optimize Neurocognitive Functions in Older Adults

Functional Magnetic Resonance Imaging Clinical Trial

— ViCTOR  

Official title:

Strategic Training to Optimize Neurocognitive Functions in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988829
• Other study ID #: IRB 20-06
• Secondary ID: 1R56AG060052-01
• Status: Completed
• Phase: N/A
• Start date: September 30, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2020
• Source: The University of Texas at Dallas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the present randomized control trial is to evaluate the efficacy of a novel cognitive training approach using simulated games, where older adults will learn to flexibly deploy attentional control during working memory, for prevention of Alzheimer's Disease (AD). Based on our extensive pilot work, we expect training-related enhancements in both neural and cognitive functions on a broad range of cognitive abilities due to the importance of attentional control and working memory in many types of cognition. These outcomes are widely applicable to the cognitive health and the quality of life of elderly Americans, and have further potential to offset degenerative processes common to normal aging.

Description:

Almost all older adults experience cognitive frailty with age, with around one-third of adults aged 85 or older suffering from Alzheimer's disease (AD). Cognitive frailty, particularly AD, threatens to overwhelm medical resources in the United States and much of the developed world. Therefore, it is important that we learn how to optimize and maintain cognitive performance in cognitively-frail older adults, particularly those who are at high risk of suffering from AD, such as adults over 70 years of age where more than half express AD pathology. The present multi-arm randomized control trial takes a novel theory-driven approach to enhancing cognition in older adults by training them to flexibly deploy attentional focus in working memory. Flexibility in allocating and switching attentional resources will be trained by having participants respond to unpredictable cues in working memory. The ability to flexibly and efficiently allocate attentional control underlies successful performance on a broad array of cognitive tasks. Hence, training in this area may enhance performance not only on related tasks (near transfer) but also on tasks that are perceptibly not related to the training task (far transfer).

The current proposal has three training arms and utilizes game-based simulations in all arms in healthy older adults. The first two arms use experimenter-designed simulation games, where participants will be trained on either predictable low attentional control (Arm 1) or unpredictable high attentional control (Arm 2) working memory games. The third arm uses a commercially available strategy game requiring the highest level of attentional control, by adding multi-tasking to the unpredictable attentional shifts in working memory. In all three training arms, neural and cognitive changes in near (secondary outcome) and far (primary outcome) transfer tasks will be examined immediately after the intervention; cognitive changes will also be assessed at 6-month post-training duration. Additionally, a single-session, baseline neuroimaging data (no training) will be collected in a functional control group of younger adults. We expect that the high attentional control training arms will greatly improve both near and far cognition in older adults, with cognitive frailty interacting with the extent to which attentional control is trained. High attentional control training arms are also expected to heighten compensatory brain activation after the intervention, for both near and far in-scanner transfer tasks, mimicking the baseline activity of younger brains. These training arms are also expected to positively impact brain structures that progressively decline with aging. This clinical trial will result in the development of behavioral intervention tools, which will have the potential to delay the onset of memory-related disorders, such as AD, by instantiating durable improvements in cognitive functions in older adults. Such interventions can not only improve an individual's quality of life but also decrease the financial burden of a rapidly aging society.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• At least a 10th grade education

• Learned English before age 5

• If female, not pregnant or likely to be pregnant

• Right-handed

• Mini Mental State (MMSE) score of 26 or greater (for older adults only), Montreal Cognitive Assessment (MoCA) score of 24 or more (for older adults only)

• The physical and sensory capacity sufficient to undertake a functional magnetic resonance imaging study

Exclusion Criteria:

• Color blindness assessed by the Ishihara Test for Color Deficiency

• Visual acuity of less than 20/30 on the Snellen eye chart after correction

• Diagnosis of any major psychiatric or neurologic disorders

• History of cardiovascular disease other than treated hypertension

• Illness or trauma affecting the central nervous system

• Substance/alcohol abuse, and medication with anti-depressants, anti-psychotics, or hypnotics other than occasionally at bedtime

• Structural magnetic resonance imaging reveal evidence of pathology (e.g. infarction)

Related Conditions & MeSH terms

• Cognitive Aging
• Functional Magnetic Resonance Imaging

Intervention

Behavioral:
• Low-C
This is the active control group, where participants will be trained to play an experimenter developed game that requires least attentional control among all arms.
• High-C
In this intervention, participants will be trained on this experimenter developed game which requires a lot of attentional control.
• High-C+
A commercial video game will be used that requires a lot of demand on attentional control.

Locations

Country	Name	City	State
United States	The Center for Vital Longevity (UT Dallas)	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas at Dallas	National Institute on Aging (NIA), University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immediate Change in the Composite Score of Reasoning	Change in composite score of Reasoning from baseline to post-training (i.e., after 8 weeks of training). The composite score of reasoning will include correct responses from 2 tasks: Matrix Reasoning; Visual Puzzle; For all tasks, alternative forms will be used for baseline testing and for post-training.	9-10 weeks (includes baseline assessment, training, and post-training assessment)
Other	Immediate Change in the Composite Score of Working Memory Capacity	Change in composite score of Working Memory Capacity from baseline to post-training (i.e., after 8 weeks of training). The composite score of working memory capacity will include correct responses from 2 tasks: List Sorting Working Memory; Complex Span; For all tasks, alternative forms will be used for baseline testing and for post-training.	9-10 weeks (includes baseline assessment, training, and post-training assessment)
Other	6-month Change in the Composite Score of Reasoning	Change in composite score of Reasoning from baseline to 6-months after completion of training (i.e., after 8 weeks of training). The composite score of reasoning will include correct responses from 2 tasks: Matrix Reasoning; Visual Puzzle; For all tasks, alternative forms will be used for baseline testing and at 6-months after completion of training.	8 months (=6 mo of retention + 9-10 weeks)
Other	6-month Change in the Composite Score of Working Memory Capacity	Change in composite score of Working Memory Capacity from baseline to 6-months after completion of training (i.e., after 8 weeks of training). The composite score of working memory capacity will include correct responses from 2 tasks: List Sorting Working Memory; Complex Span; For all tasks, alternative forms will be used for baseline testing and at 6-months after completion of training.	8 months (=6 mo of retention + 9-10 weeks)
Other	Immediate Change in the Composite Score of Psychosocial Functioning - MIDUS-II	Change in composite score of Psychosocial Functioning from baseline to post-training (i.e., after 8 weeks of training). The composite score of psychosocial functioning will include correct responses from 4 tasks: MIDUS-II; Cognitive Reserve Index; Rivermead Behavioral Memory Test - III; New general Self-efficacy Scale; For all tasks, alternative forms will be used for baseline testing and for post-training.	9-10 weeks (includes baseline assessment, training, and post-training assessment)
Other	6-month Change in the Composite Score of Psychosocial Functioning - MIDUS-II	Change in composite score of Psychosocial Functioning from baseline to 6-months after completion of training (i.e., after 8 weeks of training). The composite score of psychosocial functioning will include correct responses from 4 tasks: MIDUS-II; Cognitive Reserve Index; Rivermead Behavioral Memory Test - III; New general Self-efficacy Scale; For all tasks, alternative forms will be used for baseline testing and at 6-months after completion of training.	8 months (=6 mo of retention + 9-10 weeks)
Other	Immediate Change in Processing Speed	Change in numbers of items correctly coded within 2 minutes on the Digit Symbol Substitution task from baseline to post-training (i.e., after 8 weeks of training).; Alternative forms will be used for baseline testing and for post-training.	9-10 weeks (includes baseline assessment, training, and post-training assessment)
Other	6-month Change in Processing Speed	Change in numbers of items correctly coded within 2 minutes on the Digit Symbol Substitution task from baseline to post-training (i.e., after 8 weeks of training).; Alternative forms will be used for baseline testing and at 6-months after completion of training.	8 months (=6 mo of retention + 9-10 weeks)
Primary	Immediate Change in the Composite Score of Episodic Memory	Change in composite score of episodic memory from baseline to post-training (i.e., after 8 weeks of training). The composite score of episodic memory will include correct responses from 3 episodic memory tasks: Picture Sequence Memory; Rey Auditory Verbal Learning Test (RAVLT); Story Recall (MMSE); For all tasks, alternative forms will be used for baseline testing and for post-training. Details of the tasks are listed below: Participants are asked to reproduce a sequence of pictures that is shown on the screen.; Fifteen words are read to participants. Immediately after, the participant is asked to recall the entire list. This is repeated a few times.; A short story is read to participant. Immediately after, the participant is asked to repeat the story.	9-10 weeks (includes baseline assessment, training, and post-training assessment)
Primary	6-month Change in the Composite Score of Episodic Memory	Change in composite score of episodic memory from baseline to 6-months after completion of training (i.e., after 8 weeks of training). The composite score of episodic memory will include correct responses from 3 episodic memory tasks: Picture Sequence Memory; RAVLT; Story Recall (MMSE)	8 months (=6 mo of retention + 9-10 weeks)
Secondary	Immediate Change in the Composite Score of Executive Control	Change in composite score of episodic memory from baseline to post-training (i.e., after 8 weeks of training). The composite score of executive control will include correct responses from 6 tasks: Task Switching Response Time (RT); Dimensional Change Accuracy; Flanker RT; Stroop RT; Visual N-back RT; Verbal Memory Updating Accuracy; For all tasks, alternative forms will be used for baseline testing and for post-training.	9-10 weeks (includes baseline assessment, training, and post-training assessment)
Secondary	6-month Change in the Composite Score of Executive Control	Change in composite score of executive control from baseline to 6-months after completion of training (i.e., after 8 weeks of training). The composite score of executive control will include correct responses from 6 tasks: Task Switching RT; Dimensional Change Accuracy; Flanker RT; Stroop RT; Visual N-back RT; Verbal Memory Updating Accuracy; Alternate forms will be used at baseline and at 6-months after completion of training.	8 months (=6 mo of retention + 9-10 weeks)