Understanding how stress affects cognitive decline in people at risk for Alzheimer's disease
Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease (Stress-AD)
This study is testing how stress affects thinking skills in people with mild cognitive impairment who are at risk for Alzheimer's disease to see if certain genes and stress responses can help predict their decline.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05795634 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 and older with mild cognitive impairment who can provide informed consent and participate in follow-up visits.
Not a fit: Patients with major psychiatric illnesses, neurological disorders, or those currently smoking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to targeted interventions for individuals at risk of Alzheimer's disease, potentially slowing cognitive decline.
How similar studies have performed: While the relationship between stress and cognitive decline is established, this specific approach focusing on genetic factors and acute stress responses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.