Clinical trial NCT03988829: Strategic Training to Optimize Neurocognitive Functions in Older Adults
Official title: Strategic Training to Optimize Neurocognitive Functions in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Aging
Functional Magnetic Resonance Imaging
Keywords: randomized control trial
cognitive training
simulation games
improving brain function
improving cognition
functional magnetic resonance imaging
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
name: National Institute on Aging (NIA)
First posted: 2019-06-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will conduct a randomized control trial on healthy older adults, where attentional control demands in cognitive training will be systematically increased using engaging game-based simulations. There are three parallel arms: predictable low attentional control (Arm 1: Low-C), unpredictable high attentional control (Arm 2: High-C), and a commercially-available strategy video game (Arm 3: High-C+). In all three training arms, neural and cognitive changes in both near and far tasks will be examined immediately after the 8-week long intervention. Long-term cognitive changes will also be assessed at 6 months after completion of training. The far and near cognitive outcomes that will be examined are episodic memory (the primary cognitive outcome) and executive control (the secondary cognitive outcome).

Additionally, a single-session functional neuroimaging dataset will be collected in a functional control group of younger adults; they will not undergo any intervention.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Immediate Change in the Composite Score of Episodic Memory
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: 6-month Change in the Composite Score of Episodic Memory
timeFrame: 8 months (=6 mo of retention + 9-10 weeks)
Secondary outcomes:
measure: Immediate Change in the Composite Score of Executive Control
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: 6-month Change in the Composite Score of Executive Control
timeFrame: 8 months (=6 mo of retention + 9-10 weeks)
Other outcomes:
measure: Immediate Change in the Composite Score of Reasoning
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: Immediate Change in the Composite Score of Working Memory Capacity
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: 6-month Change in the Composite Score of Reasoning
timeFrame: 8 months (=6 mo of retention + 9-10 weeks)
measure: 6-month Change in the Composite Score of Working Memory Capacity
timeFrame: 8 months (=6 mo of retention + 9-10 weeks)
measure: Immediate Change in the Composite Score of Psychosocial Functioning - MIDUS-II
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: 6-month Change in the Composite Score of Psychosocial Functioning - MIDUS-II
timeFrame: 8 months (=6 mo of retention + 9-10 weeks)
measure: Immediate Change in Processing Speed
timeFrame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
measure: 6-month Change in Processing Speed
timeFrame: 8 months (=6 mo of retention + 9-10 weeks)
Locations:
city: Dallas
country: United States
facility: The Center for Vital Longevity (UT Dallas)
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Chandramallika Basak, PhD
role: PRINCIPAL_INVESTIGATOR
References: