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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if extra cognitive training sessions can help Veterans maintain their mental and daily skills after initial treatment. The focus is on Veterans aged 55 and older with mild cognitive impairment, who live independently and have completed a similar treatment in the past. Participants must have taken part in a specific cognitive rehabilitation study. The trial will compare the effects of Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules to regular treatment to assess which is more effective. As an unphased trial, this study provides Veterans the opportunity to contribute to innovative research that could enhance cognitive health strategies.

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 prior data suggests that these cognitive training boosters are safe for veterans?

Research has shown that Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) is generally safe for individuals with mild memory and thinking problems. Studies have not identified any specific safety issues, indicating that most people can handle it without difficulty. ME-CCT aims to improve thinking skills without using drugs, typically resulting in fewer side effects. Participants in similar studies have generally tolerated the treatment well, according to past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules because they offer a fresh approach to managing mild cognitive impairment. Unlike the standard care options, which often rely on medications and lifestyle changes, ME-CCT focuses on enhancing cognitive skills through targeted training sessions. This technique leverages motivational strategies to boost engagement and effectiveness, potentially providing a more proactive and empowering way for individuals to manage their cognitive challenges. By integrating motivation with cognitive training, ME-CCT aims to not only improve cognitive function but also enhance the quality of life for those affected.

What evidence suggests that ME-CCT Booster Modules could be effective for mild cognitive impairment?

Research shows that Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) can improve thinking skills in people with mild memory problems. In this trial, participants will either receive ME-CCT Booster Training or continue with Treatment as Usual. Previous studies have found that ME-CCT can reduce risk factors for memory decline, making daily tasks easier and enhancing mental abilities. ME-CCT is particularly noted for increasing motivation and involvement, which can enhance the effectiveness of cognitive training. Some studies also suggest that ME-CCT can improve sleep and increase physical activity, both beneficial for brain health. Overall, these findings suggest that ME-CCT could effectively maintain and improve mental functions in aging Veterans. ^{2 6 7 8 9}

Who Is on the Research Team?

Jacqueline E Maye, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 '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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05770479

Study Details | NCT05770479 | Assessing and Improving the ... Evidence supports the effectiveness ... Behavioral : Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules ... Mild Cognitive Impairment" ...

2. escholarship.org escholarship.org/content/qt6wr3f1d5/qt6wr3f1d5_noSplash_353ed210bae84cf260633da36d7c8ee9.pdf

Effects of Motivationally Enhanced Compensatory ... Thus, this dissertation study examined the efficacy of an 8-week Motivationally. Enhanced Compensatory Cognitive Training (ME-CCT) intervention, ...

3. withpower.com withpower.com/trial/cognitive-training-boosters-for-mild-cognitive-impairment-47da2

Cognitive Training Boosters for Mild Cognitive Impairment ... 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 ...

4. cogtale.org cogtale.org/wp-content/uploads/2023/05/Motivationally-Enhanced-Compensatory-Cognitive-Training-for-MCI-2.pdf

Motivationally Enhanced Compensatory Cognitive Training ... By reducing modifiable risk factors and increasing protective factors, you may improve cognitive recovery and outcomes. Page 9. From: Motivationally Enhanced ...

5. digitalcollections.sdsu.edu digitalcollections.sdsu.edu/do/8288ea35-fa77-4b3f-99f5-d811dd958caa

Effects of motivationally enhanced compensatory cognitive ... Mixed-effects models examined whether (1) ME-CCT, compared to SC, was associated with greater improvements in self-rated PA levels and sleep disturbance; and (2) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06330844

Race-Based Stress and Cognitive Training for MCI This a two phase project that aims to pilot a new adaptation (Phase 1) of Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6415132/

Computerised cognitive training for preventing dementia in ... To evaluate the effects of at least 12 weeks of computerised cognitive training (CCT) on maintaining or improving cognitive function and preventing dementia

8. withpower.com withpower.com/trial/cognitive-training-for-mild-cognitive-impairment-294ef

Cognitive Training for Mild Cognitive Impairment The available research does not report any specific safety concerns for cognitive training in people with mild cognitive impairment, suggesting it is generally ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06134128

Compensatory Cognitive Training Via Telehealth for ... Motivationally Enhanced Compensatory Cognitive Training for Addictions (ME-CCT-A) is a manualized group-based behavioral intervention (8 weeks, 2 hour per week) ...