Cognitive Training Boosters for Mild Cognitive Impairment

(AID-CCT Trial)

Overseen By Elizabeth W Twamley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use disorder, Schizophrenia, Brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

28 Participants Needed

Trial Summary

What is the purpose of this trial?

Veterans have numerous risk factors (e.g., PTSD, TBI, cerebrovascular problems) for later-life cognitive and functional decline. Evidence supports the effectiveness of strategy-based cognitive rehabilitation therapies, including compensatory cognitive training (CCT), for such decline. However, questions remain about the length of time that CCT-driven improvements in cognitive and everyday function last, and whether additional 'booster' training sessions could provide additional benefit to aging Veterans who previously underwent treatment. This study examines the long-term durability of CCT in Veterans aged 55+ and provides an opportunity to develop and pilot test a series of CCT booster sessions that can be personalized toward individual everyday functional goals.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules for Mild Cognitive Impairment?

Research shows that cognitive training programs, including computer-based ones, can improve memory, attention, and mood in people with mild cognitive impairment. Participants in these studies reported fewer everyday memory problems and better mood after training. ^{1 2 3 4 5}

Is cognitive training safe for people with mild cognitive impairment?

The studies reviewed suggest that cognitive training, including computer-based and game-based methods, is generally safe for people with mild cognitive impairment, with high adherence and satisfaction reported by participants. ^{4 5 6 7 8}

How does cognitive training differ from other treatments for mild cognitive impairment?

Cognitive training for mild cognitive impairment is unique because it involves computer-based exercises designed to improve specific mental skills like attention, processing speed, and memory, rather than using medication. This approach focuses on enhancing brain function through practice and mental exercises, which may lead to improvements in everyday cognitive tasks and mood. ^{1 2 3 7 9}

Research Team

Jacqueline E Maye, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

This trial is for Veterans aged 55+ who can consent, live independently, speak English, and have completed a prior 'Cognitive Rehabilitation' study. It's not for those with recent substance abuse, significant brain injury (loss of consciousness >30 mins), participation in certain sub-studies, or severe auditory/visual impairments.

Inclusion Criteria

I am a veteran aged 55 or older and can make my own medical decisions.

I live on my own without needing daily help.

English-speaking: necessary to complete cognitive and functional testing and participate in booster development and other study procedures

Exclusion Criteria

Participation in sub-study 2 of this CDA

I do not have hearing or vision problems that would stop me from joining in learning sessions.

I have had a severe brain injury with unconsciousness for over 30 minutes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants undergo neuropsychological and functional capacity tests, and complete self-reports of quality of life and daily function

1 week

1 visit (in-person)

Treatment

Participants receive either 3-4 booster intervention modules/sessions or treatment as usual

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the same battery of tests and questionnaires as the initial assessment

4 weeks

Treatment Details

Interventions

• Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules

Trial Overview The study tests the long-term benefits of Compensatory Cognitive Training (CCT) in older Veterans. It compares usual treatments to additional personalized 'booster' sessions aimed at enhancing cognitive function and daily living skills.

Participant Groups

Group I: Treatment as Usual Experimental Treatment 1 Intervention

Treatment as Usual

Group II: ME-CCT Booster Training Experimental Treatment 1 Intervention

3-4 Sessions of ME-CCT Booster Training

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

In a study involving two older adults with Amnestic Mild Cognitive Impairment, cognitive training led to improved performance on untrained measures of attention and reasoning for one participant after 40 training sessions.

Both participants reported fewer cognitive failures in daily life and improved mood after completing the training, suggesting potential benefits of cognitive training beyond the specific tasks practiced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single case study of computerised cognitive training for older persons with mild cognitive impairment. Finn, M., McDonald, S.[2018]

The COGNIPLAT cognitive training game significantly improved cognitive performance in elderly participants with mild cognitive impairment (MCI), as evidenced by notable enhancements in various cognitive tests after 24 training sessions.

Participants in the intervention group showed high engagement and completion rates, with a 91% completion rate and 100% attendance for follow-up, indicating that the platform is not only effective but also well-received and usable by the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Effects of Cognitive Training with the COGNIPLAT Game Platform in Elderly with Mild Cognitive Impairment: Pilot Randomized Controlled Trial. Goumopoulos, C., Skikos, G., Frounta, M.[2023]

The 'Tablet Enhancement of Cognition and Health' (TECH) intervention showed high feasibility and satisfaction among older adults with and without mild cognitive impairment (MCI), with 28 participants with MCI and 10 with pre-MCI reporting positive experiences.

Participants with MCI demonstrated significant improvements in memory recall and cognitive assessments, suggesting that TECH may help preserve cognitive function over time, although further research is needed to confirm its long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Daily Practice of Puzzle-Game Apps on Cognition in Two Groups of Older Adults: A Pre-Post Experimental Study. Givon Schaham, N., Buckman, Z., Rand, D.[2023]

A pilot study involving 47 participants with mild cognitive impairment showed that intensive, computer-based cognitive training improved neuropsychological assessment scores by 0.36 standard deviations, although this was not statistically significant compared to the control group.

The study suggests that while the cognitive training may have specific benefits for verbal learning and memory, further research with larger sample sizes is needed to confirm these effects and explore their potential domain-specific impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. Barnes, DE., Yaffe, K., Belfor, N., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A single case study of computerised cognitive training for older persons with mild cognitive impairment. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

DUPLICATE: The effectiveness of a cognitive training program in people with mild cognitive impairment: A study in urban community. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The effectiveness of a cognitive training program in people with mild cognitive impairment: A study in urban community. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Effect of computerised cognitive training on cognitive outcomes in mild cognitive impairment: a systematic review and meta-analysis. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Effects of Cognitive Training with the COGNIPLAT Game Platform in Elderly with Mild Cognitive Impairment: Pilot Randomized Controlled Trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Daily Practice of Puzzle-Game Apps on Cognition in Two Groups of Older Adults: A Pre-Post Experimental Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Protocols for cognitive enhancement. A user manual for Brain Health Services-part 5 of 6. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The Construction and Evaluation of Executive Attention Training to Improve Selective Attention, Focused Attention, and Divided Attention for Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial. [2020]