Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT05795634

Conditions

Mild Cognitive Impairment

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Trier Social Stress Test

Study Details

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.

Conditions

Mild Cognitive Impairment

Alzheimer Disease

Study ID

NCT05795634

Start date

Mar 1, 2023

Status verified date

Jan, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Trier Social Stress Test

All participants in the study will get undergo the same stress procedure

Interventions

Trier Social Stress Test

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

Primary outcome measure

  • 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 mean executive test composite score [ Time Frame: Baseline and Visit 2 (up to 1 month) and Baseline to Visit 3 (up to 2 years) ]

Central Contacts and Locations

Central contacts

Cynthia A Munro, PhD

410-550-6271cmunro@jhmi.edu

Nicholas Bienko, MS

410-550-2036nbienko1@jhmi.edu

Locations

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Nick Bienko, MA

410-550-2036nbienko1@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Keywords

  • Stress
  • Neuropsychology
  • Endocrine
  • Genetics
  • Blood biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-01-29.