PRogram to Improve Stress-levels and Enhance Memory
Completed · Not applicable
Conditions studied: Mild Cognitive Impairment
In brief
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.
Key facts
- Study ID
- NCT05845918
- Run by
- Emory University
- People needed
- 45
- Starts
- 2023-02-21
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2026-05-28
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age: 50 years or older
- Fluency in English
- African American or White
- MCI will be defined as subjective memory complaints with a Montreal Cognitive Assessment (MoCA) 19- 25
- Prior diagnosis of MCI
- Participants would be 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)
You may not qualify if…
- Dementia diagnosis or reversible causes of dementia (e.g., if the patient has hypothyroidism or low vitamin B12 that is contributing to the subject's cognitive impairment)
- Active medical or psychiatric diseases that in the judgment of the investigator would affect the safety of the subject or scientific integrity of the study (e.g., actively manic patient)
- Uncontrolled medical conditions, such as congestive heart failure, reflected by poor exercise tolerance and shortness of breath
- Any physical ailment, such as stroke with residual impairment, that is a barrier to performing study procedures and attending sessions
- History of brain lesions, stroke, or major head trauma in the past year
- Those who are unable to demonstrate that they understood the details of the study (i.e., lack of decisional- capacity to consent) or linguistic limitations
- Pregnant women, prisoners, and adults unable to consent
Where it is running
- Emory Goizueta Alzheimer's Disease Research Center (GADRC) — Atlanta, Georgia, United States
- Emory Dunwoody Clinic — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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