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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new program aimed at improving thinking and mental health in older adults with mild memory and cognitive challenges. The study tests a new version of a cognitive training method that considers the impact of stress related to race and discrimination. Participants will be divided into two groups: one will try the new program, Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI), while the other will use the original version, Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT). Individuals who self-identify as Black/African American and experience mild memory issues are well-suited for this trial. As an unphased trial, this study provides participants the opportunity to contribute to innovative research that could lead to improved 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's best to discuss this with the study team or your doctor.

What prior data suggests that this cognitive training is safe for individuals with mild cognitive impairment?

Research has shown that the Motivationally Enhanced Compensatory Cognitive Training (ME-CCT) program, which forms the basis for the new RBSEF-CCT-MCI treatment, has been used safely in previous studies. This program includes exercises to improve thinking and memory skills. Participants in past trials generally tolerated it well, with no major safety issues reported.

The new version, RBSEF-CCT-MCI, focuses on race-related stress and empowerment. Although this specific version is new, its components have been tested for safety in other studies. These studies have demonstrated that addressing stress and empowerment can be safe and helpful.

This study is in the "Not Applicable" phase, meaning the main goal is to assess the treatment's effectiveness, not its safety. Earlier research suggests the treatment is expected to be safe. However, as with any clinical trial, researchers will closely monitor participants for any unexpected effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI) because it introduces a novel approach to tackling mild cognitive impairment (MCI). Unlike traditional treatments that often focus on medications or generalized cognitive exercises, RBSEF-CCT-MCI specifically addresses the unique stressors faced by individuals due to racial experiences, aiming to empower participants while enhancing cognitive function. This tailored approach not only targets cognitive deficits but also considers emotional and social factors, which could lead to more effective and personalized outcomes for those affected by MCI.

What evidence suggests that this trial's treatments could be effective for mild cognitive impairment?

Research has shown that addressing race-related stress can enhance coping mechanisms and improve mental well-being. A previous small study found that a similar method, called RiSE, helped African American women manage racism and adopt healthy coping strategies. In this trial, participants in the experimental arm will receive the new RBSEF-CCT-MCI treatment, which combines mental exercises with addressing race-related stress. This dual approach aims to enhance both mental health and cognitive skills, such as memory, for those with mild cognitive impairment. While researchers are still gathering direct evidence for RBSEF-CCT-MCI, its components have shown promise in related areas. Meanwhile, participants in the control group will complete the original ME-CCT training program. ^{1 2 3 5 6}

Who Is on the Research Team?

Rachael L Ellison, PhD

Principal Investigator

Rosalind Franklin University of Medicine and Science

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. 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 ...

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

Cognitive Training 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12048792/

The Effectiveness of a Race-Based Stress Reduction ... Our previous pilot study found that RiSE improved the ability of African American women to cope with racism and increased the use of adaptive coping strategies ...

4. malacards.org malacards.org/card/mild_cognitive_impairment

Mild Cognitive Impairment Integrated disease information for Mild Cognitive Impairment including associated genes, mutations, phenotypes, pathways, drugs, and more - integrated from ...

5. researchgate.net researchgate.net/publication/389331355_The_effectiveness_of_a_race-based_stress_reduction_intervention_RiSE_on_improving_stress-related_symptoms_and_inflammation_in_African_American_women_at_risk_for_cardiometabolic_disease_protocol_for_re

(PDF) The effectiveness of a race-based stress reduction ... cognitive restructuring surrounding race-based trauma is used. ... Results: Participation in RiSE was associated with a more rapid decline ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05422638?titles=RBSTE&rank=1

Race-Based Stress Trauma and Empowerment ( RBSTE ) An innovative clinical program, the Race-Based Stress/Trauma and Empowerment (RBSTE) group, was developed to help Veterans of Color to build coping resources ...