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RECRUITING

NCT05795634

Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn about how genetics and the response to stress predicts cognitive decline in individuals with mild cognitive impairment. The main question\[s\] it aims to answer are: * Does the hormone response to acute stress predict the degree of cognitive impairment following acute stress? * Do genes associated with the risk for Alzheimer's disease influence the relationship between stress hormone response to stress and cognitive impairment following stress? * Do cognitive impairment following acute stress and genes associated with the risk for Alzheimer's disease predict cognitive decline and change in biomarkers for Alzheimer's disease 2 years later? Participants will have 3 in-person study visits. The first 2 will occur at baseline and the 3rd visit will occur 2 years later. During the visits, participants will provide blood and saliva samples, undergo a 10-minute social stress procedure, complete questionnaires, and take tests of memory and other thinking skills. Someone who knows the participant (a "study partner") will be asked questions about the participant's daily functioning at the first and 3rd study visits.

Official title: Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease (Stress-AD)

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2023-03-01

Completion Date

2029-03-01

Last Updated

2026-01-29

Healthy Volunteers

Conditions

Mild Cognitive Impairment Alzheimer Disease

Interventions

BEHAVIORAL

Trier Social Stress Test

Acute psychosocial stress procedure; 5 minutes of public speaking and 5 minutes of mental arithmetic

Inclusion Criteria for Subjects with Mild Cognitive Impairment (MCI) * Age 60 and older * Fluent English speaker * Able to provide informed consent for study procedures * Willing and able to return for 2-year-followup visit * Willing and able to provide an informant who can participate in the screening and 2-year study visits * BMI \>17 and \<30 * Meets clinical and cognitive criteria for mild cognitive impairment (MCI) using National Institute on Aging (NIA)/Alzheimer's Association 2011 criteria (see below) Exclusion Criteria for Subjects with MCI * Current smoker * Current or past history of major psychiatric illness, including schizophrenia, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder * Neurological disorder, including Parkinson's disease, Huntington's disease * Current or past history of immune disorder, including multiple sclerosis * Current or past history of drug dependence * Treatment within the last six months with: neuroleptics, sedative hypnotics, or glucocorticoids * History of head injury with loss of consciousness for more than ½ hour, stroke, or seizure * General surgery within the last 3 months * Sensory impairment (poor vision or hearing) significant enough to interfere with ability to provide valid cognitive test data Clinical and Cognitive Criteria for MCI due to AD * Cognitive concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time) * Objective evidence of impairment in one or more cognitive domains, typically including memory (i.e., formal or bedside testing to establish level of cognitive function in multiple domains) * Preservation of independence in functional abilities * Not demented * Etiology of MCI consistent with AD pathophysiological process Inclusion Criteria for Study Partners * Age 21 or older * Able to participate in an interview * Willing and able to attend study visits * Willing and able to return for 2-year-followup visit Exclusion Criteria for Study Partners • Unwilling to answer questions about the participant with MCI

Locations (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, United States