PRogram to Improve Stress-levels and Enhance Memory

Mild Cognitive Impairment Clinical Trial

— PRISEM  

Official title:

PRogram to Improve Stress-levels and Enhance Memory

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05845918
• Other study ID #: STUDY00004811
• Secondary ID: 1K23AG066931-01A
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Emory University
• Contact: Ambar Kulshreshtha, MD, PhD
• Phone: 404-778-6910
• Email: mindandheart[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 an in-person and 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• PRISEM CEP
Participants in PRISEM CEP will undergo assessment and goal setting during the intake process to ensure that the program meets their needs. All participants partake in lifestyle programs in individual or group-based in-person activities that address cognitive, physical, social, and functional independence, education, and well-being goals.
• PRISEM Remote
Participants will attend 1-hour sessions weekly for 12 weeks (12 sessions) then biweekly for 8 weeks (4 sessions) and 1 session in the last month (1 session). Sessions will be group-based and will cover the following topics: 1) Program Overview, 2) Get Active, 3)Track Activity, 4) Eating Well, 5) Track Food, 6) Get More Active, 7) Energy In, Energy Out, 8) Eating to Support Health Goals, 9) Manage Stress, 10) Eat Well Away From Home, 11) Managing Triggers, 12) How to Stay Active, 13) Take Charge of Thoughts, 14) Get Back on Track, 15) Get Support (from friends and family), and 16) Staying Motivated. Sessions will include a brief presentation of the topic, followed by an introduction to tools and strategies to practice. This is a facilitated program with participants "driving" the direction and acting as peer support to one another.

Locations

Country	Name	City	State
United States	Emory Dunwoody Clinic	Atlanta	Georgia
United States	Emory Goizueta Alzheimer's Disease Research Center (GADRC)	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility for the PRISEM pilot to collect additional stress and vascular measures in participants in both PRISEM groups	Feasibility will be calculated as the percentage of participants agreeing to participate (n=60) enrolled as per target with a loss to follow up.	6 months
Primary	Change in the acceptability for the PRISEM pilot to collect additional stress and vascular measures.	Acceptability of the PRISEM pilot participants will be assessed using semi-structured interviews regarding vascular and stress measures conducted over the course of the study.	Baseline, 6 months, and 9 months
Secondary	Change in Perceived Stress Scale (PSS) score	The questions in the PSS ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all 10 scale items. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.	Baseline, 6 months, and 9 months
Secondary	Change in the short form (SF)-12 Quality of Life (QoL) score	The SF-12 QoL uses two items each to estimate scores for four to eight health concepts (physical functioning, role-physical, role-emotional, and mental health). Scores for the remaining four health concepts (bodily, pain, general health, vitality, and social functioning) are estimated using one item each. The lower the score the more disability.	Baseline, 6 months, and 9 months
Secondary	Change in weight	weight (Kg) will be measured at each study timepoint	Baseline, 6 months, and 9 months
Secondary	Change in BMI	Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI will be calculated at each study timepoint.	Baseline, 6 months, and 9 months
Secondary	Change in systolic and diastolic blood pressure (BP) measurements	Systolic and diastolic blood pressure (SBP and DBP)will be measured at each time point. BP (mmHg) will be assessed by utilizing an automatic sphygmomanometer in which a cuff will be placed on the participant's forearm.	Baseline, 6 months, and 9 months
Secondary	Change in the heart rate variability (HRV).	Heart rate variability (HRV) will be measured with an ECG monitor. A validated signal processing code will be used to evaluate these signals for noise and detect the necessary ECG component measures, and when outliers are suspected, a visual inspection will be performed. If any episodes of Atrial fibrillation are detected by the program, they will be confirmed by the study team and excluded. HRV will be examined in 5-minute sliding windows, and the median, 10th percentile, and minimum values will be calculated.	Baseline, 6 months, and 9 months
Secondary	Effect of the multicomponent intervention programs on Pulse Wave Analyses changes.	Indices of arterial stiffness and wave reflections will be estimated in the supine position using the Sphygmocor device (Atcor Medical, Australia), which records sequential high-quality pressure waveforms at peripheral pulse sites using a high-fidelity tonometer. Pulse-wave velocity (PWV) measured between carotid and femoral arteries is a regional assessment of aortic stiffness and is the gold standard index of arterial stiffness.	Baseline, 6 months, and 9 months
Secondary	Effect of the multicomponent intervention programs on measures of cognitive executive function tests.	Participants will complete several questionnaires that assess executive cognitive function, which are prerequisites to any purposeful and goal-directed action. They allow one to generate plans, and solutions to problems, or organizational structures that guide future action. They rely on working memory, mental flexibility, and retrieval of relevant information from semantic and episodic memory stores.	Baseline, 6 months, and 9 months