Lifestyle Interventions for Mild Cognitive Impairment

(PRISEM Trial)

Recruiting at 1 trial location

Overseen By Ambar Kulshreshtha, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Dementia, Uncontrolled conditions, Stroke, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a pilot study with the objective to examine if an in-person and a remote multi-component intervention program can improve chronic stress, vascular measures, and executive function among African American and White patients with Mild Cognitive Impairment. Researchers plan to enroll 45 participants with over-recruitment of African American patients. Participants will be recruited to participate in PRogram to Improve Stress-levels and Enhance Memory (PRISEM) (i.e., remote lifestyle intervention program). The participants will be asked to participate in group-based and/or individual activities that focus on improving health education, nutrition, physical activity, cognitive health, stress levels, and overall well-being. The duration of the study for all participants will be 12 months with 3 study visits. At each study visit, the following measures will be assessed: psychosocial, behavioral, vascular/physical, and executive function.

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.

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 PRISEM CEP for mild cognitive impairment?

Research shows that lifestyle interventions, like the PRISEM program, can help maintain or improve cognitive function in older adults at risk for dementia. Programs that focus on multiple lifestyle factors, such as diet and exercise, have been found to be feasible and potentially beneficial for cognitive and mental health outcomes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment PRISEM CEP for mild cognitive impairment?

Research shows that lifestyle interventions, like the PRISEM program, can help improve or maintain cognitive function in older adults at risk for dementia. Programs that target multiple lifestyle factors, such as diet and exercise, have been found to improve cognitive and psychosocial outcomes in people with mild cognitive impairment. ^{1 2 3 4 5}

Is the PRISEM Lifestyle Intervention Program safe for humans?

The available research does not provide specific safety data for the PRISEM Lifestyle Intervention Program or its variants. However, similar non-pharmacological interventions for cognitive impairment, like cognitive rehabilitation and remote memory clinics, are generally considered safe and have been used to support cognitive health in older adults. ^{1 2 6 7 8}

Is the PRISEM Lifestyle Intervention Program safe for humans?

The available research does not provide specific safety data for the PRISEM Lifestyle Intervention Program or its variants. However, similar non-pharmacological interventions, like cognitive rehabilitation and remote memory clinics, are generally considered safe and have been used to support cognitive health in individuals with mild cognitive impairment or dementia. ^{1 2 6 7 8}

How is the PRISEM Cognitive Empowerment Program treatment different from other treatments for mild cognitive impairment?

The PRISEM Cognitive Empowerment Program is unique because it is a remotely delivered lifestyle intervention that combines multiple approaches, such as physical activity, diet, and social engagement, to improve cognitive function and mental health in older adults, making it more accessible compared to traditional face-to-face programs. ^{2 3 4 6 9}

How is the PRISEM Cognitive Empowerment Program treatment different from other treatments for mild cognitive impairment?

The PRISEM Cognitive Empowerment Program is unique because it is a remotely delivered lifestyle intervention that combines multiple strategies to improve cognitive function, making it more accessible for older adults at risk for dementia. Unlike traditional face-to-face programs, it uses virtual methods to target modifiable lifestyle risk factors, such as physical activity and diet, to help maintain cognitive health. ^{2 3 4 9 10}

Research Team

Ambar Kulshreshtha, MD, PhD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for African American and White individuals aged 50 or older with mild cognitive impairment (MCI), who speak English fluently, are generally inactive, and have poor diet habits related to brain health. It's not for those with dementia, uncontrolled medical conditions like heart failure, major physical impairments from stroke or trauma, or anyone unable to consent.

Inclusion Criteria

Participants sedentary at baseline (self-report of <30 minutes of structured physical activity <3 times per week in the last 6 months) and have poor Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet scores (using the MIND diet screener)

African American or White

MCI defined as subjective memory complaints with a Montreal Cognitive Assessment (MoCA) score of 19-25

Exclusion Criteria

I have heart issues that make it hard for me to exercise or breathe.

I do not have any active medical or mental health conditions that could affect my safety or the study's results.

I have a physical condition that makes it hard for me to participate in study activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a remote lifestyle intervention program with 17 core online sessions over 6 months

6 months

3 visits (in-person)

Follow-up

Participants are monitored for changes in stress, vascular measures, and cognitive function

6 months

3 visits (in-person)

Treatment Details

Interventions

• PRISEM CEP
• PRISEM Remote

Trial Overview The study tests two programs: PRISEM CEP (an in-person lifestyle intervention) and PRISEM Remote (a similar program but conducted remotely). Both aim to improve stress levels, vascular health, and executive function over a period of 9 months through activities focusing on health education, nutrition, exercise, cognitive health and overall well-being.

Participant Groups

Group I: PRISEM Remote Experimental Treatment 1 Intervention

PRISEM Remote is a remote-based lifestyle intervention program in which participants will attend 17 core online sessions via Zoom from the evidence-based Diabetes Prevention Program curriculum with remaining post-core sessions to reinforce strategies and activities introduced in the core program for the duration of 6 months.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The MAXCOG intervention, a home-based cognitive rehabilitation program, significantly improved goal performance and satisfaction for clients with mild cognitive impairment (MCI) or early dementia, as shown in a randomized controlled trial with 55 client-supporter dyads.

Out of the participants, 25 dyads completed the MAXCOG sessions, demonstrating that personalized interventions can effectively address individual goals, leading to better outcomes compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MAXCOG-Maximizing Cognition: A Randomized Controlled Trial of the Efficacy of Goal-Oriented Cognitive Rehabilitation for People with Mild Cognitive Impairment and Early Alzheimer Disease. Regan, B., Wells, Y., Farrow, M., et al.[2022]

The virtual cognitive health (VC Health) program, a remotely delivered multidomain lifestyle intervention, significantly improved cognitive function in older adults with subjective cognitive decline, with an average increase of 5.8 points in the RBANS Total Index score over 52 weeks (P<.001).

Participants also experienced significant reductions in depression and anxiety levels, with mean decreases of 3.8 points in the PHQ-9 score and 2.9 points in the GAD-7 score, indicating the program's effectiveness in enhancing mental health outcomes alongside cognitive improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of the Virtual Cognitive Health Program on the Cognition and Mental Health of Older Adults: Pre-Post 12-Month Pilot Study. Kumar, S., Tran, J., Moseson, H., et al.[2020]

Patients with mild cognitive impairment (MCI) showed significant improvements in daily living activities, mood, and both verbal and nonverbal episodic memory after participating in a 4-week multi-component cognitive rehabilitation program.

In contrast, patients with mild dementia experienced only a non-significant increase in verbal memory, highlighting that the rehabilitation program may be more beneficial for those with MCI than for those with more advanced cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in patients with mild cognitive impairment. Kurz, A., Pohl, C., Ramsenthaler, M., et al.[2022]

The My Healthy Brain program, an 8-week group-based lifestyle intervention delivered via live video, effectively targets multiple lifestyle risk factors for dementia in older adults with cognitive decline or mild cognitive impairment.

Participants reported that the program was feasible and acceptable, suggesting it has the potential to improve lifestyle, cognitive, and psychosocial outcomes for at-risk older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

My Healthy Brain: Rationale and Case Report of a Virtual Group Lifestyle Program Targeting Modifiable Risk Factors for Dementia. Mace, RA., Hopkins, SW., Reynolds, GO., et al.[2023]

Cognitive intervention programs for individuals with mild cognitive impairment of the amnestic type (MCI-A) showed statistically significant improvements in memory, with 44% of objective memory measures and 49% of subjective measures (like quality of life and mood) demonstrating positive outcomes after training.

The review highlighted the need for larger sample sizes and more robust experimental designs in future studies to enhance the efficacy and standardization of cognitive interventions for MCI-A.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive intervention programs for individuals with mild cognitive impairment: systematic review of the literature. Jean, L., Bergeron, ME., Thivierge, S., et al.[2022]

The TV-AssistDem project is a 12-month multicenter randomized controlled trial involving 240 older adults in Spain and Romania, aimed at improving the quality of life for individuals with mild cognitive impairment or mild dementia through a TV-based platform.

The platform offers various services such as health monitoring, cognitive stimulation, and caregiver education, and is expected to enhance not only patient quality of life but also reduce caregiver burden and improve treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TV-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (TV-AssistDem): study protocol for a multicentre randomized controlled trial. Goodman-Casanova, JM., Guzmán-Parra, J., Guerrero, G., et al.[2023]

This study is testing the effectiveness of a computer-based cognitive rehabilitation program delivered at home (HomeCoRe) compared to in-person sessions (CoRe) for participants with Mild or Major Neurocognitive Disorders, involving 40 participants over a 6-week period.

The goal is to determine if HomeCoRe is as effective as CoRe, which could support the use of telerehabilitation for ongoing care in cognitive decline, making treatment more accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HomeCoRe for Telerehabilitation in Mild or Major Neurocognitive Disorders: A Study Protocol for a Randomized Controlled Trial. Bernini, S., Panzarasa, S., Sinforiani, E., et al.[2022]

Remote memory clinics provide easier access to cognitive assessments and non-pharmacological treatments for dementia, allowing for early intervention without the need for in-person visits.

Sensor technology plays a crucial role in monitoring cognitive decline and facilitating health education, enabling scalable and cost-effective solutions for a wide range of populations, from those at risk to individuals with late-stage dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Broadened assessments, health education and cognitive aids in the remote memory clinic. Owens, AP., Krebs, C., Kuruppu, S., et al.[2023]

The study highlights Mild Cognitive Impairment (MCI) as a significant risk factor for dementia, emphasizing the importance of lifestyle factors like physical activity, Mediterranean diet, reading, and socialization in potentially reducing this risk.

The 'Camminando e leggendo… ricordo' (CLR) model is introduced as a secondary prevention program for older adults with MCI, combining physical and reading activities to promote healthier lifestyles and improve overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mild cognitive impairment, from theory to practical intervention: "Camminando e leggendo… ricordo" (Walking and reading… I remember), an action plan. The Treviso Dementia (TREDEM) Registry. Gallucci, M., Mazzetto, M., Spagnolo, P., et al.[2017]

In a study involving 24 group sessions with people with mild cognitive impairment (MCI) and their care partners, withholding yoga from the Mayo Clinic HABIT program resulted in the greatest decline in functional ability over 18 months, highlighting the importance of physical exercise in maintaining cognitive function.

Memory compensation training and cognitive exercises were associated with better functional outcomes, suggesting that specific lifestyle modifications can effectively support individuals with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effects of Physical Exercise and Other Behavioral Interventions on Functional Status Outcomes in Mild Cognitive Impairment. Shandera-Ochsner, AL., Chandler, MJ., Locke, DE., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

MAXCOG-Maximizing Cognition: A Randomized Controlled Trial of the Efficacy of Goal-Oriented Cognitive Rehabilitation for People with Mild Cognitive Impairment and Early Alzheimer Disease. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

The Impact of the Virtual Cognitive Health Program on the Cognition and Mental Health of Older Adults: Pre-Post 12-Month Pilot Study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in patients with mild cognitive impairment. [2022]

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

My Healthy Brain: Rationale and Case Report of a Virtual Group Lifestyle Program Targeting Modifiable Risk Factors for Dementia. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Cognitive intervention programs for individuals with mild cognitive impairment: systematic review of the literature. [2022]

6. England pubmed.ncbi.nlm.nih.gov

TV-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (TV-AssistDem): study protocol for a multicentre randomized controlled trial. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

HomeCoRe for Telerehabilitation in Mild or Major Neurocognitive Disorders: A Study Protocol for a Randomized Controlled Trial. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Broadened assessments, health education and cognitive aids in the remote memory clinic. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

Mild cognitive impairment, from theory to practical intervention: "Camminando e leggendo… ricordo" (Walking and reading… I remember), an action plan. The Treviso Dementia (TREDEM) Registry. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Comparative Effects of Physical Exercise and Other Behavioral Interventions on Functional Status Outcomes in Mild Cognitive Impairment. [2022]