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

This study is looking at how stress affects thinking and memory in people with mild cognitive impairment (MCI), a condition that can sometimes lead to Alzheimer's disease. Researchers will use a behavioral intervention called the Trier Social Stress Test (a public speaking and mental arithmetic task) to create acute stress. They want to see if your body's hormone response to stress and your genes linked to Alzheimer's disease predict how much your memory and executive function (planning, problem-solving) change after stress, and over two years. The study aims to enroll 240 participants aged 60 and older who have MCI. Success would mean understanding how stress vulnerability might help identify people who could benefit from specific Alzheimer's treatments. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 240 participants. It is not specified if it is randomized or blinded.
What's involved
You would have three in-person study visits. These visits will involve undergoing the Trier Social Stress Test and completing a battery of cognitive tests.
Compensation
Not stated in the trial record.
Follow-up
Your memory and executive function will be measured at baseline, up to 1 month later, and up to 2 years later.

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NCT05795634

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

Recruiting
NAAges 60+InterventionalDiagnostic
Johns Hopkins University
~240 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:Trier Social Stress Test

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in mean memory test composite score
Measured over Baseline and Visit 2 (up to 1 month) and Baseline to Visit 3 (up to 2 years)
+1 more outcome measured
Mild Cognitive Impairment
Alzheimer Disease
1 sites across 1 states
Maryland1
  • Cynthia A Munro, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins School of Medicine

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Eligibility criteria

Inclusion

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

Exclusion

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
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
  • Change in mean memory test composite scoreBaseline 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 scoreBaseline 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