Understanding how stress affects cognitive decline in people at risk for Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the relationship between stress responses and cognitive decline in individuals with mild cognitive impairment (MCI) who are at risk for Alzheimer's disease. Participants will undergo a Trier Social Stress Test to induce acute stress, followed by cognitive assessments and biological sample collection over a two-year period. The study aims to determine if genetic factors and stress hormone responses can predict cognitive impairment and subsequent decline. By focusing on these associations, the trial seeks to identify specific vulnerabilities that could inform future Alzheimer's interventions.

Why it matters

Who can join: the full rules

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 it's running

• Johns Hopkins School of Medicine
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Cynthia A Munro, PhD — Johns Hopkins School of Medicine
• Study coordinator: Cynthia A Munro, PhD
• Email: cmunro@jhmi.edu
• Phone: 410-550-6271

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.