Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT05795634

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

Led by Johns Hopkins University · Updated on 2026-01-29

240

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial 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. 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

Official Title

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

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 and older
  • Fluent English speaker
  • Able to provide informed consent for study procedures
  • Willing and able to return for 2-year follow-up visit
  • Willing and able to provide an informant who can participate in the screening and 2-year study visits
  • BMI greater than 17 and less than 30
  • Meets clinical and cognitive criteria for mild cognitive impairment (MCI) using National Institute on Aging (NIA)/Alzheimer's Association 2011 criteria
  • Cognitive concern reflecting a change in cognition reported by patient, informant, or clinician
  • Objective evidence of impairment in one or more cognitive domains, typically including memory
  • Preservation of independence in functional abilities
  • Not demented
  • Etiology of MCI consistent with Alzheimer's disease pathophysiological process
  • 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 follow-up visit
Not Eligible

You will not qualify if you...

  • 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 half an 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
  • For study partners: Unwilling to answer questions about the participant with MCI

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Johns Hopkins School of Medicine

Baltimore, Maryland, United States, 21224

Actively Recruiting

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Research Team

C

Cynthia A Munro, PhD

CONTACT

N

Nicholas Bienko, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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