Strategic Training to Optimize Neurocognitive Functions in Older Adults

NCT03988829 | Completed

• 2 other identifiers: IRB 20-061R56AG060052-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Aging; Functional Magnetic Resonance Imaging

Keywords

randomized control trial; cognitive training; simulation games; improving brain function; improving cognition; functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

• 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: 1. Picture Sequence Memory 2. Rey Auditory Verbal Learning Test (RAVLT) 3. 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: 1. Participants are asked to reproduce a sequence of pictures that is shown on the screen. 2. Fifteen words are read to participants. Immediately after, the participant is asked to recall the entire list. This is repeated a few times. 3. 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)

• 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: 1. Picture Sequence Memory 2. RAVLT 3. Story Recall (MMSE)

  8 months (=6 mo of retention + 9-10 weeks)

Secondary Outcomes (2)

• Immediate Change in the Composite Score of Executive Control

  9-10 weeks (includes baseline assessment, training, and post-training assessment)

• 6-month Change in the Composite Score of Executive Control

  8 months (=6 mo of retention + 9-10 weeks)

Other Outcomes (8)

• Immediate Change in the Composite Score of Reasoning

  9-10 weeks (includes baseline assessment, training, and post-training assessment)

• Immediate Change in the Composite Score of Working Memory Capacity

  9-10 weeks (includes baseline assessment, training, and post-training assessment)

• 6-month Change in the Composite Score of Reasoning

  8 months (=6 mo of retention + 9-10 weeks)

Study Arms (3)

Low-C

ACTIVE COMPARATOR

In an experimenter-designed simulation game, participants will be trained on predictable low attentional control shifts during working memory.

Behavioral: Low-C

High-C

EXPERIMENTAL

In an experimenter-designed simulation game, participants will be trained on unpredictable high attentional control shifts during working memory.

Behavioral: High-C

High-C+

EXPERIMENTAL

In this commercially-available video game, in addition to unpredictable shifts of attentional control in working memory, task switching and resource planning will be trained.

Behavioral: High-C+

Interventions

Low-C BEHAVIORAL

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.

Also known as: Predictable Bird Watch

Low-C

High-C+ BEHAVIORAL

A commercial video game will be used that requires a lot of demand on attentional control.

Also known as: Video Game

High-C+

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• University of Texas Southwestern Medical Center: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The Center for Vital Longevity (UT Dallas)

Dallas, Texas, 75235, United States

Location

Study Officials

• Chandramallika Basak, PhD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: If a volunteer meets the inclusion and exclusion criteria, he or she will be randomized into one of the three training arms. This assignment will be based on a random computerized allocation plan, where the average cognitive frailty, age, education and gender distribution will be maintained to be equivalent across the three arms. To maintain the balance between the arms, we will randomize between blocks of 15 participants. By randomly assigning participants in the training arms and by assessing outcomes by blinded experimenters, we will avoid selection bias and outcome assessment bias. No masking is required for the younger adults, as they will not be undergoing any training. The PI will be blinded to training assignment of any subject, and will only analyze de-identified data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: June 18, 2019
• Study Start: September 30, 2018
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: January 28, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)