Cognitive AgingViCTORNCT03988829
Strategic Training to Optimize Neurocognitive Functions in Older Adults
A study testing Low-C, High-C and High-C+ in people with Cognitive Aging and Functional Magnetic Resonance Imaging, run by The University of Texas at Dallas at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Aging, Functional Magnetic Resonance Imaging
- What is being tested?
- Low-C, High-C and High-C+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2018to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Vital Longevity (UT Dallas)
Dallas, Texas, 75235
About this study
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.
Read the 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.
- Being tested
- Low-C, High-C, High-C+
- Keywords
- randomized control trial, cognitive training, simulation games, improving brain function, improving cognition, functional magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-CBehavioural
Also called Predictable Bird Watch
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-CBehavioural
Also called Unpredictable Bird Watch
In this intervention, participants will be trained on this experimenter developed game which requires a lot of attentional control.
High-C+Behavioural
Also called Video Game
A commercial video game will be used that requires a lot of demand on attentional control.
| Study group | Role | What they receive |
|---|---|---|
| Low-C | Active comparator | In an experimenter-designed simulation game, participants will be trained on predictable low attentional control shifts during working memory. Receives: 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. Receives: 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. Receives: Behavioral: High-C+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- Picture Sequence Memory
- RAVLT
- Story Recall (MMSE)
Measured: 8 months (=6 mo of retention + 9-10 weeks)
Secondary outcomes (2)
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.
Measured: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
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.
Measured: 8 months (=6 mo of retention + 9-10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start30 Sep 2018
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Chandramallika Basak, PhD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988829
- Sponsor's protocol ID
- IRB 20-06
- Other IDs
- 1R56AG060052-01
- Acronym
- ViCTOR
- Status last verified
- Nov 2020
- First submitted
- 10 May 2019
- Last updated
- 28 Jan 2022
- 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 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Training to Optimize Neurocognitive Functions in Older Adults
- ClinicalTrials.gov ID
- NCT03988829
- Acronym / sponsor ID
- ViCTOR / IRB 20-06
- Keywords
- randomized control trial, cognitive training, simulation games, improving brain function, improving cognition, functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, National Institute on Aging (NIA)
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 18 Jun 2019 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low-C | Active comparator | Behavioral: Low-CIn an experimenter-designed simulation game, participants will be trained on predictable low attentional control shifts during working memory. |
| High-C | Experimental | Behavioral: High-CIn an experimenter-designed simulation game, participants will be trained on unpredictable high attentional control shifts during working memory. |
| High-C+ | Experimental | Behavioral: High-C+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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Low-CAlso: Predictable Bird WatchThis is the active control group, where participants will be trained to play an experimenter developed game that requires least attentional control among all arms. | Behavioural | Low-C |
| High-CAlso: Unpredictable Bird WatchIn this intervention, participants will be trained on this experimenter developed game which requires a lot of attentional control. | Behavioural | High-C |
| High-C+Also: Video GameA commercial video game will be used that requires a lot of demand on attentional control. | Behavioural | High-C+ |
Primary outcome
Immediate Change in the Composite Score of Episodic Memory
Time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
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.
6-month Change in the Composite Score of Episodic Memory
Time frame: 8 months (=6 mo of retention + 9-10 weeks)
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)
2 secondary outcomes
Immediate Change in the Composite Score of Executive Control
Time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
6-month Change in the Composite Score of Executive Control
Time frame: 8 months (=6 mo of retention + 9-10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Cognitive Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Feasibility of A Smartphone Application Intervention in Community Settings: A Pretest-Posttest Pilot Study
Aging, Dementia
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
Enrolling by invitationObservational study
Comorbidity, Cognition, Gait Speed, and Respiratory Muscle Strength in Older Adults
Geriatrics, Older Adults (60 - 85 Years Old)
Recruiting
Effects of Breathing Exercises on Cognition in Older Adults
Older Adults (65 Years and Older), Cognition
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. This study is not recruiting at the moment.
Chandramallika Basak, PhD principal investigator
The University of Texas at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-C, High-C and High-C+ in people with Cognitive Aging and Functional Magnetic Resonance Imaging, run by The University of Texas at Dallas 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 28 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Change in the Composite Score of Episodic Memory (time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)). 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 28 Jan 2022.