NCT05795634 · Johns Hopkins University
Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease
(Stress-AD)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Trier Social Stress Test
Acute psychosocial stress procedure; 5 minutes of public speaking and 5 minutes of mental arithmetic
Primary outcome measures
Change in mean memory test composite score
Time frame: Baseline and Visit 2 (up to 1 month) and Baseline to Visit 3 (up to 2 years)
Change in the mean composite score of the following memory tests: Neuropsychological Assessment Battery Word List Memory test, Morris Revision test, and a computerized Pattern Separation Task, with higher composite score indicating better memory
Change in mean executive test composite score
Time frame: Baseline and Visit 2 (up to 1 month) and Baseline to Visit 3 (up to 2 years)
Change in the mean composite score of the following executive tests: phonemic (letter) fluency test, part B of the Trial Making Test, and the backwards trial of a Digit Span task, with higher composite score indicating better executive functioning
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2026 · Source of record for eligibility and locations