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

Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease (Stress-AD)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits
  • Procedures mentioned: Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "For this study, participants will come to the clinic for 3 study visits."
  • "At that visit, the investigators will ask participants to provide another blood sample and complete tests of memory and other thinking skills."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how genes and stress affect memory and thinking in adults age 60 and older with mild cognitive impairment, or mild memory and thinking problems. It will also look at changes in thinking skills and signs of Alzheimer's disease after 2 years. Participants will have 3 visits with blood and saliva samples, a short stress task, and memory and thinking tests.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 60 or older and speak English fluently.
  • Be able to understand the study and agree to take part.
  • Be willing and able to return for a visit after 2 years.
  • Have a study partner who knows you and can take part in screening and the 2-year visit.
  • Have a body mass index (BMI), a measure of weight compared with height, above 17 and below 30.
  • Have mild memory or thinking problems that fit the study's criteria for changes linked to Alzheimer's disease. Changes must be noticed by you or someone else and shown on tests.
  • Still be able to do daily activities independently and not have dementia.
  • Study partners must be at least 21, able to answer interview questions, and willing and able to attend visits, including the 2-year visit.

Who can't join

  • Currently smoke or have a current or past history of drug dependence.
  • Have or have had a major mental health illness, such as schizophrenia, bipolar disorder, obsessive-compulsive disorder, or post-traumatic stress disorder.
  • Have a brain or nerve disorder, such as Parkinson's or Huntington's disease, or a current or past immune system disorder, such as multiple sclerosis.
  • Used antipsychotic medicines, medicines for sleep or sedation, or glucocorticoids (steroid medicines) in the past 6 months.
  • Have had a stroke, seizure, or head injury that made you lose consciousness for more than 30 minutes.
  • Had general surgery in the past 3 months.
  • Have vision or hearing problems severe enough to affect memory and thinking test results.
  • Study partners cannot take part if they are unwilling to answer questions about the participant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

MD