Lifestyle Interventions for Mild Cognitive Impairment (PRISEM Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByAmbar Kulshreshtha, MD, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Emory University
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a 2-arm intervention 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 60 participants with over-recruitment of African American patients. 30 participants will be recruited from the Cognitive Empowerment Program to participate in PRogram to Improve Stress-levels and Enhance Memory (PRISEM) Cognitive Empowerment Program (CEP) (i.e., in-person lifestyle intervention program) and 30 participants will be recruited from Emory primary care clinics to participate in PRISEM Remote (i.e., remote lifestyle intervention program). The participants in both intervention arms 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 9 months with 3 study visits. At each study visit, the following measures will be assessed: psychosocial, behavioral, vascular/physical, and executive function.
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.
13568Is 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.
45679What 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.
12468Will 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.
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.Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: PRISEM RemoteExperimental Treatment1 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.
Group II: PRISEM CEP (in-person)Experimental Treatment1 Intervention
The Cognitive Empowerment Program (CEP) is an in-person lifestyle intervention program in which participants participate in individual or group-based activities that address cognitive, physical, social, and functional independence, education, and well-being goals.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Emory Dunwoody ClinicAtlanta, GA
Emory Goizueta Alzheimer's Disease Research Center (GADRC)Atlanta, GA
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Who is running the clinical trial?
Emory UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Cognitive rehabilitation in patients with mild cognitive impairment. [2022]To explore the benefits of a multi-component cognitive rehabilitation programme in patients with mild cognitive impairment (MCI).
Cognitive intervention programs for individuals with mild cognitive impairment: systematic review of the literature. [2022]This systematic literature review addressed the efficacy of 15 cognitive intervention programs that have been tested in individuals presenting with mild cognitive impairment of the amnestic type (MCI-A) possibly at risk to progress toward dementia. MEDLINE, PsycINFO, and Current Content databases were searched using the following key terms: cognitive training, cognitive stimulation, cognitive rehabilitation, neuropsychological intervention, memory training, memory stimulation, and Mild Cognitive Impairment. The data showed statistically significant improvements at the end of training on 44% of objective measures of memory, when compared with 12% of objective measures of cognition other than memory. Statistically significant improvements after treatment were obtained on 49% of subjective measures of memory, quality of life, or mood. Samples sizes ranged from 1 to 193 patients with MCI-A but were usually
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]Dementia is one of the most disabling health conditions in older people. Increasing attention is paid to the preclinical phase of dementia and to the prevention programs to reduce the number of patients in the future. Aims of the current study are: a) to present Mild Cognitive Impairment (MCI) as a heterogeneous risk factor and to expose the relationship between cognitive impairment and lifestyles such as physical activity, Mediterranean diet, reading and socialization; b) to present a model, called "Camminando e leggendo… ricordo" (CLR), as a practical experience of secondary prevention aimed at MCI older people. The CLR model is composed of a program of physical and reading activities in group to promote healthy lifestyles. Here we present a protocol to evaluate the effectiveness of our intervention model. A multidimensional geriatric assessment will be carried out. A questionnaire for the detection of frailty, disability and for the adherence to the Mediterranean diet will be administered. The Psychological General Well-Being Index (PGWBI) will be used to assess the quality of life. CLR is an intervention model for secondary prevention in MCI subjects. It is the description of a practical proposal aimed at improving lifestyles and reducing the risk of dementia.
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]To review the efficacy of a home-based four-session individualized face-to-face cognitive rehabilitation (MAXCOG) intervention for clients with mild cognitive impairment (MCI) or early dementia and their close supporters.
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]Mild cognitive impairment and mild dementia progressively compromise the ability of people to live independently and can have a negative impact on their quality of life. Within the current European Active and Assisted Living programme (AAL), project TV-AssistDem has been developed to deliver a TV-based platform service to support patients with mild cognitive impairment or mild dementia and provide relief to their caregivers. The application is intended to be used daily at home, mainly by the participants themselves, with the help of their informal caregivers. The aim of this study is to evaluate the effectiveness of TV-AssistDem to improve quality of life in people with mild cognitive impairment or mild dementia.
The Impact of the Virtual Cognitive Health Program on the Cognition and Mental Health of Older Adults: Pre-Post 12-Month Pilot Study. [2020]Face-to-face multidomain lifestyle interventions have shown to be effective for improving or maintaining cognitive function in older adults at risk for dementia. Remotely delivered interventions could increase access to such solutions but first require evidence to support that these programs can successfully impact health outcomes.
HomeCoRe for Telerehabilitation in Mild or Major Neurocognitive Disorders: A Study Protocol for a Randomized Controlled Trial. [2022]Background: Given the limited effectiveness of pharmacological treatments for cognitive decline, non-pharmacological interventions have gained increasing attention. Evidence exists on the effectiveness of cognitive rehabilitation in preventing elderly subjects at risk of cognitive decline and in reducing the progression of functional disability in cognitively impaired individuals. In recent years, telerehabilitation has enabled a broader application of cognitive rehabilitation programs. The purpose of this study is to test a computer-based intervention administered according to two different modalities (at the hospital and at home) using the tools CoRe and HomeCoRe, respectively, in participants with Mild or Major Neurocognitive Disorders. Methods: Non-inferiority, single-blind randomized controlled trial where 40 participants with Mild or Major Neurocognitive Disorders will be assigned to the intervention group who will receive cognitive telerehabilitation through HomeCoRe or to the control group who will receive in-person cognitive intervention through CoRe, with the therapist administering the same computer-based exercises. The rehabilitative program will last 6 weeks, with 3 sessions/week, each lasting ~45 min. All the participants will be evaluated on an exhaustive neuropsychological battery before (T0) and after (T1) the intervention; follow-up visits will be scheduled after 6 (T2) and 12 months (T3). Discussion: The results of this study will inform about the comparability (non-inferiority trial) of HomeCoRe with CoRe. Their equivalence would support the use of HomeCoRe for at distance treatment, favoring the continuity of care. Ethics and Dissemination: This study has been approved by the Local Ethics Committee and registered in https://clinicaltrials.gov (NCT04889560). The dissemination plan includes the scientific community through publication in open-access peer-reviewed scientific journals and presentations at national and international conferences. Trial Registration: Clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT04889560 (registration date: May 17, 2021).
My Healthy Brain: Rationale and Case Report of a Virtual Group Lifestyle Program Targeting Modifiable Risk Factors for Dementia. [2023]Nearly half of dementia cases may be explained by modifiable lifestyle risk factors. Multidomain interventions are needed to bypass cognitive decline (CD) and aging-related barriers to sustained healthy lifestyles in at-risk older adults. We iteratively developed My Healthy Brain, a group-based lifestyle program (8 weeks, 90 min sessions) delivered via live video that applies behavioral principles to target multiple risk factors for dementia. We describe the program structure, virtual delivery, and outcomes for a group of older adults with subjective CD or mild cognitive impairment and lifestyle risk factors (e.g., sedentary, poor sleep or diet). We also conducted a group exit interview to qualitatively assess participant experiences and elicit feedback to improve My Healthy Brain. This case report demonstrates that delivering evidence-based brain health education and behavior change skills in a group setting via live video is feasible, acceptable, and has the potential to improve lifestyle, cognitive, and psychosocial outcomes in older adults with CD.
Broadened assessments, health education and cognitive aids in the remote memory clinic. [2023]The prevalence of dementia is increasing and poses a health challenge for individuals and society. Despite the desire to know their risks and the importance of initiating early therapeutic options, large parts of the population do not get access to memory clinic-based assessments. Remote memory clinics facilitate low-level access to cognitive assessments by eschewing the need for face-to-face meetings. At the same time, patients with detected impairment or increased risk can receive non-pharmacological treatment remotely. Sensor technology can evaluate the efficiency of this remote treatment and identify cognitive decline. With remote and (partly) automatized technology the process of cognitive decline can be monitored but more importantly also modified by guiding early interventions and a dementia preventative lifestyle. We highlight how sensor technology aids the expansion of assessments beyond cognition and to other domains, e.g., depression. We also illustrate applications for aiding remote treatment and describe how remote tools can facilitate health education which is the cornerstone for long-lasting lifestyle changes. Tools such as transcranial electric stimulation or sleep-based interventions have currently mostly been used in a face-to-face context but have the potential of remote deployment-a step already taken with memory training apps. Many of the presented methods are readily scalable and of low costs and there is a range of target populations, from the worried well to late-stage dementia.