Lifestyle Interventions for Mild Cognitive Impairment

(PRISEM Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether lifestyle changes can help African American and White individuals with Mild Cognitive Impairment (MCI) manage stress, improve heart health, and boost brain function. Participants will join a remote program called PRISEM (PRISEM Cognitive Empowerment Program), attending online sessions focused on health education, nutrition, physical activity, and stress management. The study suits those diagnosed with MCI, experiencing memory issues, and leading a mostly inactive lifestyle. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance quality of life.

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 prior data suggests that this intervention program is safe?

Research has shown that lifestyle programs like PRISEM are generally easy for participants to handle. Studies of similar programs indicate they help reduce stress and improve mental health without causing serious side effects. For instance, a review of programs focused on mental support found them to be safe and helpful for improving memory. Additionally, programs that teach stress management skills, like PRISM, have successfully increased resilience and reduced stress.

Reports of significant or unexpected problems with these types of programs are rare, suggesting participants usually manage them well. While the current study doesn't have results yet, existing evidence shows that lifestyle programs are typically safe and can provide a positive experience for those involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PRISEM Remote because it is a lifestyle intervention program specifically designed for individuals with mild cognitive impairment that offers a novel, remote-based approach. Unlike typical treatments like medications that focus on slowing cognitive decline, PRISEM Remote emphasizes behavior change through online sessions, drawing from the evidence-based Diabetes Prevention Program. This method not only makes it more accessible for participants by allowing them to engage from home, but it also empowers them with tools and strategies over a six-month period to potentially improve cognitive health through lifestyle modifications.

What evidence suggests that the PRISEM Remote Lifestyle Intervention Program is effective for improving mild cognitive impairment?

Research shows that lifestyle changes can benefit people with Mild Cognitive Impairment (MCI). A review found that remote programs like PRISEM Remote, studied in this trial, can improve memory and thinking skills. These programs typically include activities such as health education, exercise, and stress management. They have been shown to lower stress and boost overall well-being. Studies indicate that even small improvements in these areas can enhance brain health in older adults. Therefore, joining PRISEM Remote in this trial might improve memory and reduce stress for those with MCI. ^{1 6 7 8 9}

Who Is on the Research Team?

Ambar Kulshreshtha, MD, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-cognitive-dysfunction-1-2023-09ba4

Lifestyle Interventions for Mild Cognitive Impairment (PRISEM 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, ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05845918/program-to-improve-stress-levels-and-enhance-memory

PRogram to Improve Stress-levels and Enhance Memory The aim of this pilot study is to evaluate how a remote multicomponent lifestyle intervention program improves mood symptoms (chronic stress), ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9761296/

The effect of remotely delivered lifestyle interventions on ... We systematically reviewed randomized controlled trials of remotely delivered lifestyle interventions (≥4 weeks duration and delivered >50% remotely), for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12193062/

A PRISMA-Compliant Systematic Review and Meta-Analysis ... This review aims to systematically examine ICT-based cognitive support interventions that differ from general care or safety technologies in enhancing memory, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S156816372100252X

The effect of remotely delivered lifestyle interventions on ... This is the first systematic review and meta-analysis to evaluate the effect of remotely delivered lifestyle interventions on cognition in older adults without ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12209016/

Promoting resilience in stress management (PRISM) for ... PRISM is a manualized, skills-based, psychosocial intervention shown to promote resilience and alleviate psychological distress among adolescents and young ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/94/NCT03847194/Prot_SAP_000.pdf

The Promoting Resilience in Stress Management (PRISM) ... Data safety monitoring for the intervention will focus on assuring that subjects are not experiencing any significant or unexpected distress and that they ...

8. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/bsa3.70032

REMINDer randomized controlled study: Feasibility and ... Primary outcomes: Feasibility and changes in mental and physical well-being. Secondary outcomes: Changes in multi-domain health and lifestyle ...

9. formative.jmir.org formative.jmir.org/2025/1/e66885

Toward a Smartphone-Based and Conversational Agent ... We adopted the JITAI framework to design a low-burden, chatbot-delivered digital lifestyle intervention tailored to the behavioral needs and ...