Stress Response and Memory in Mild Cognitive Impairment
Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease
Recruiting
N/AInterventional Study
Mild Cognitive ImpairmentAlzheimer Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
240 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for older adults with mild cognitive impairment who can return for a follow-up visit in two years. Participants will provide samples, take tests of memory and thinking, and answer questions about their daily functioning.
Are You a Good Fit for This Trial?
You may be able to join if
I am 60 years old or older
I speak fluent English
I can provide informed consent
I am willing to return for a follow-up visit in two years
I can provide a study partner for visits
My BMI is between 17 and 30
I meet the criteria for mild cognitive impairment
You may not be able to join if
I am a current smoker
I have a major psychiatric illness
I have a neurological disorder
I have an immune disorder
I have a history of drug dependence
I have had surgery in the last 3 months
I have significant sensory impairment
I have had a serious head injury or seizure
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 rel…
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.
Trial Locations
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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 scree…
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
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