NCT05795634 Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease
| NCT ID | NCT05795634 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2023-03-01 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Cynthia A Munro, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins School of Medicine
Frequently Asked Questions
Who can join the NCT05795634 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05795634 currently recruiting?
Yes, NCT05795634 is actively recruiting participants. Contact the research team at cmunro@jhmi.edu for enrollment information.
Where is the NCT05795634 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05795634 clinical trial?
NCT05795634 is sponsored by Johns Hopkins University. The principal investigator is Cynthia A Munro, PhD at Johns Hopkins School of Medicine. The trial plans to enroll 240 participants.