Clinical trial NCT05845918: PRogram to Improve Stress-levels and Enhance Memory
Official title: PRogram to Improve Stress-levels and Enhance Memory
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: lifestyle intervention
Chronic Stress
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-05-06
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: More than half the patients with Mild Cognitive Impairment (MCI), a transitional state between normal aging and dementia, will develop dementia within five years. Despite the clinical and public health significance of MCI, there are no known pharmacological treatment strategies preventing the progression to Alzheimer's Disease (AD). Disappointing results from clinical trials of AD-modifying interventions have increased efforts to focus on prevention strategies that delay the onset of the disease. Since AD-related pathology begins more than a decade before patients develop symptoms, prevention efforts are likely to be more effective when targeted earlier in life. Data is even more limited on higher risk groups such as African Americans who have double the incidence compared with Whites.

This study plans to enroll a diverse population with an over-enrollment of African Americans because African Americans have a higher risk of developing mild cognitive impairment (MCI) and double the incidence of Alzheimer's Disease (AD) compared with Whites. Unfortunately, prevention and management of MCI have been understudied among African Americans. Chronic stress (such as perceived discrimination, and daily environmental stress) in African Americans can affect cognition and plays a role in the worsening of unhealthy behaviors such as smoking, improper diet, and physical inactivity.

Recent studies have predicted that a 10-25% reduction in seven key modifiable risk factors, including behavioral and lifestyle choices, could prevent 1.3 million AD cases globally. Healthy lifestyle approaches can reduce oxidative stress, produce structural and functional changes in the brain, and also influence the rate of neurogenesis in adult and senescent animal models. However, interventions that improve these have been often disappointing, in part because the impact of each lifestyle behavior on AD risk is relatively small.

The aim of this pilot study is to evaluate how a remote multicomponent lifestyle intervention program improves mood symptoms (chronic stress), and positively impacts biomarkers of vascular health and autonomic nervous system among forty African American and White patients with MCI.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility for the PRISEM pilot to collect additional stress and vascular measures in participants in both PRISEM groups
timeFrame: 6 months
measure: Change in the acceptability for the PRISEM pilot to collect additional stress and vascular measures.
timeFrame: Baseline, 6 months, and 12 months
Secondary outcomes:
measure: Change in Perceived Stress Scale (PSS) score
timeFrame: Baseline, 6 months, and 12 months
measure: Change in the short form (SF)-12 Quality of Life (QoL) score
timeFrame: Baseline, 6 months, and 12 months
measure: Change in weight
timeFrame: Baseline, 6 months, and 12 months
measure: Change in BMI
timeFrame: Baseline, 6 months, and 12 months
measure: Change in systolic and diastolic blood pressure (BP) measurements
timeFrame: Baseline, 6 months, and 12 months
measure: Change in the heart rate variability (HRV).
timeFrame: Baseline, 6 months, and 12 months
measure: Effect of the multicomponent intervention programs on Pulse Wave Analyses changes.
timeFrame: Baseline, 6 months, and 12 months
measure: Effect of the multicomponent intervention programs on measures of cognitive executive function tests.
timeFrame: Baseline, 6 months, and 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Goizueta Alzheimer's Disease Research Center (GADRC)
state: Georgia
city: Atlanta
country: United States
facility: Emory Dunwoody Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Ambar Kulshreshtha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: