NCT05795634Recruiting
Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease
Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease (Stress-AD)
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 7 Mar 2023
- Start date
- 1 Mar 2023
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- Johns Hopkins University
- Diseases
- Alzheimer disease
- NCT number
- NCT05795634
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 1 Mar 2023 to the primary completion date, 1 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- General surgery within the last 3 months
Other illness
- 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
- History of head injury with loss of consciousness for more than ½ hour, stroke, or seizure
- 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
- 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)
Other
- Current smoker
- Treatment within the last six months with: neuroleptics, sedative hypnotics, or glucocorticoids
- Cognitive concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
- Preservation of independence in functional abilities
- Not demented
- Etiology of MCI consistent with AD pathophysiological process
- Unwilling to answer questions about the participant with MCI
Who the study is looking for
- 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)
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins School of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.