Cognitive Training for Mild Cognitive Impairment

Overseen By Rachael L Ellison, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Rosalind Franklin University of Medicine and Science

Disqualifiers: Dementia, Intellectual disability, Traumatic brain injury, others

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

Compensation: Varies

Number of Visits: 16

9 Participants Needed

Trial Summary

What is the purpose of this trial?

This a two phase project that aims to pilot a new adaptation (Phase 1) of Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT; an originally VA-based cognitive rehabilitation manualized intervention for older adults with MCI, with a focus on the impact of stress on cognitive functioning; that integrates components from the Race Based Stress and Empowerment (RBSE) group for an increased focus on race-based stress and discrimination for racial minority older adults (i.e., RBSEF-CCT-MCI). In a pilot open trial, 75-150 participants will receive group-based intervention for 8 weeks, with 8-10 participants per group. Following the pilot study, the investigators will complete a randomized controlled trial (RCT) (Phase 2) to compare the efficacy of the RBSEF-CCT-MCI with the ME-CCT. In the RCT, 75-150 participants will be randomized into either 1) The active control group, who will complete the original, ME-CCT training program, or 2) The experimental group, who will complete the newly developed RBSE-CCT-MCI. Both research groups will complete the interventions for 8 weeks, with 8-10 participants per group. Hypothesis: Participation in this newly developed/updated intervention (i.e., RBSEF-CCT-MCI) will result in improvements in both (a) subjective and (b) objective cognitive functioning, and (c) self-reported mental health symptoms.

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's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT) and Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI)?

Research shows that cognitive training programs can help improve cognitive processing speed in people with mild cognitive impairment (MCI), with benefits lasting up to five years. This suggests that similar cognitive training treatments like ME-CCT and RBSEF-CCT-MCI might also be effective in maintaining cognitive function. ^{1 2 3 4 5}

Is cognitive training safe for people with 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 safe for use in humans. ^{4 6 7 8 9}

How is the RBSEF-CCT-MCI treatment different from other treatments for mild cognitive impairment?

The RBSEF-CCT-MCI treatment is unique because it combines cognitive training with a focus on addressing race-based stress and empowerment, which is not typically included in standard cognitive training programs for mild cognitive impairment. ^{2 6 10 11 12}

Research Team

Rachael L Ellison, PhD

Principal Investigator

Rosalind Franklin University of Medicine and Science

Eligibility Criteria

This trial is for older adults with mild cognitive impairment (MCI), particularly those from racial minority groups who may experience race-based stress and discrimination. Participants should be interested in group-based interventions aimed at improving cognitive functioning and mental health.

Inclusion Criteria

I can travel to Rosalind Franklin University for study visits.

Participants must self-identify as Black/African American, or self-identify with other racial/ethnic groups in addition to self-identifying as Black/African-American; may be expanded to include participants that identify as Hispanic/Latine

Exclusion Criteria

I am 65 or older and have mild memory or thinking problems.

I do not have dementia, intellectual disability, or recent severe head injuries.

I have been diagnosed with dementia, either through self-report, medical records, or cognitive tests.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Intervention

Participants receive group-based intervention for 8 weeks focusing on race-based stress and cognitive training

8 weeks

8-10 participants per group

Randomized Controlled Trial (RCT)

Participants are randomized to either the active control group (ME-CCT) or the experimental group (RBSEF-CCT-MCI) for 8 weeks

8 weeks

8-10 participants per group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT)
• Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI)

Trial Overview The study tests two types of cognitive training over 8 weeks: RBSEF-CCT-MCI, which includes a focus on race-based stress, and ME-CCT, the original program without this focus. The efficacy of these programs will be compared to see if they improve subjective and objective cognitive function as well as mental health symptoms.

Participant Groups

Group I: Experimental: RBSEF-CCT-MCI Experimental Treatment 1 Intervention

Participants will complete the newly developed RBSE-CCT-MCI training program.

Group II: Control Group: ME-CCT Experimental Treatment 1 Intervention

Participants will complete the original, ME-CCT training program.

Who Is Running the Clinical Trial?

Rosalind Franklin University of Medicine and Science

Lead Sponsor

Trials

15

Recruited

690+

Findings from Research

Cognitive speed of processing training (SOPT) was effective in improving cognitive function in older adults with mild cognitive impairment (MCI), with all subtypes showing immediate benefits post-training compared to controls.

The single non-amnestic subtype of MCI experienced the most significant improvements, and all subtypes maintained their training gains over five years, suggesting the durability of SOPT's effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of cognitive speed of processing training among older adults with psychometrically- defined mild cognitive impairment. Valdes, EG., O'Connor, ML., Edwards, JD.[2019]

The study involved 66 older adults with mild cognitive impairment (MCI) who participated in a virtual interactive working memory training (VIMT) program, showing a significant improvement in working memory compared to an active control group after 36 training sessions.

The VIMT program not only helped maintain working memory but also potentially reduced cognitive decline in older adults with MCI, indicating its efficacy as an intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. Yang, HL., Chu, H., Kao, CC., et al.[2020]

References

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

Computerized cognitive assessment of mild cognitive impairment in urban African Americans. [2022]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The effects of cognitive speed of processing training among older adults with psychometrically- defined mild cognitive impairment. [2019]

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

A Closer Look at Practice Effects in Mild Cognitive Impairment and Alzheimer's Disease. [2023]

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

Preventing cognitive decline in older African Americans with mild cognitive impairment: design and methods of a randomized clinical trial. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Group- and Home-Based Cognitive Intervention for Patients with Mild Cognitive Impairment: A Randomized Controlled Trial. [2022]

6. China pubmed.ncbi.nlm.nih.gov

Cognitive Training in Older Adults with Mild Cognitive Impairment. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Correlates of psychological distress in study partners of older people with and without mild cognitive impairment (MCI) - the Sydney Memory and Ageing Study. [2016]

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

Effect of cognitive training on the expression of brain-derived neurotrophic factor in lymphocytes of mild cognitive impairment patients. [2016]

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

Feasibility of a Telehealth Compensatory Cognitive Training Program for Older Adults with Mild Cognitive Impairment. [2023]

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

Can Cognitive Speed of Processing Training Improve Everyday Functioning Among Older Adults With Psychometrically Defined Mild Cognitive Impairment? [2021]

11. England pubmed.ncbi.nlm.nih.gov

Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of an Innovative Cognitive Treatment and Telerehabilitation on Subjects With Mild Cognitive Impairment: A Multicenter, Randomized, Active-Controlled Study. [2022]