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Lifestyle Interventions for Mild Cognitive Impairment (PRISEM Trial)

N/A

Recruiting

Led By Ambar Kulshreshtha, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, and 9 months

Awards & highlights

PRISEM Trial Summary

This trial is exploring if lifestyle interventions can help improve stress and memory for people with mild cognitive impairment. 60 participants will do activities focusing on health, nutrition, physical activity, cognitive health, and stress. The study will last 9 months with 3 visits.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the interventions involve lifestyle changes rather than medication there may be minimal side effects such as muscle soreness from increased physical activity or adjustment issues to new dietary habits. However specific side effects will depend on individual experiences.

PRISEM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, and 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, and 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the acceptability for the PRISEM pilot to collect additional stress and vascular measures.

Feasibility for the PRISEM pilot to collect additional stress and vascular measures in participants in both PRISEM groups

Secondary outcome measures

Change in BMI

Change in Perceived Stress Scale (PSS) score

Change in systolic and diastolic blood pressure (BP) measurements

+5 more

PRISEM Trial Design

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,638 Previous Clinical Trials

2,560,472 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,017,003 Total Patients Enrolled

Ambar Kulshreshtha, MD, PhDPrincipal InvestigatorEmory University

1 Previous Clinical Trials

31 Total Patients Enrolled

Media Library

PRISEM CEP Clinical Trial Eligibility Overview. Trial Name: NCT05845918 — N/A

Mild Cognitive Impairment Research Study Groups: PRISEM Remote, PRISEM CEP (in-person)

Mild Cognitive Impairment Clinical Trial 2023: PRISEM CEP Highlights & Side Effects. Trial Name: NCT05845918 — N/A

PRISEM CEP 2023 Treatment Timeline for Medical Study. Trial Name: NCT05845918 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for this investigation?

"Affirmative. Clinicaltrials.gov has evidence that this clinical trial is presently recruiting participants, which was first announced on February 21st 2023 and updated most recently in April 25th 2023. At present, 60 people are being sought between two locations."

Answered by AI

What aims are researchers attempting to accomplish through this trial?

"This clinical trial, which spans 6 months and will be evaluated all the way through, seeks to assess the acceptability of PRISEM's pilot in collecting additional stress and vascular metrics. Secondary objectives include obtaining change scores for SF-12 Quality of Life (QoL), weight, and Body Mass Index (BMI)."

Answered by AI

How many individuals have registered to partake in this scientific trial?

"Affirmative. Clinicaltrials.gov denotes that recruitment for this clinical trial has commenced; the announcement was initially made on February 21st 2023 and was recently updated on April 25th 2023. The study is seeking a total of 60 participants at 2 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRogram to Improve Stress-levels and Enhance Memory

Ambar Kulshreshtha 2023. "PRogram to Improve Stress-levels and Enhance Memory". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05845918.