Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease
Stress-AD
2 other identifiers
interventional
240
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
January 29, 2026
January 1, 2026
5 years
March 7, 2023
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in mean memory test composite score
Change in the mean composite score of the following memory tests: Neuropsychological Assessment Battery Word List Memory test, Morris Revision test, and a computerized Pattern Separation Task, with higher composite score indicating better memory
Baseline and Visit 2 (up to 1 month) and Baseline to Visit 3 (up to 2 years)
Change in mean executive test composite score
Change in the mean composite score of the following executive tests: phonemic (letter) fluency test, part B of the Trial Making Test, and the backwards trial of a Digit Span task, with higher composite score indicating better executive functioning
Baseline and Visit 2 (up to 1 month) and Baseline to Visit 3 (up to 2 years)
Secondary Outcomes (1)
Change (in nanogram per liter; ng/L) in level of neurofilament light (NF-L)
Baseline to Visit 3 (up to 2 years)
Study Arms (1)
Trier Social Stress Test
OTHERAll participants in the study will get undergo the same stress procedure
Interventions
Acute psychosocial stress procedure; 5 minutes of public speaking and 5 minutes of mental arithmetic
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Johns Hopkins School of Medicine
Baltimore, Maryland, 21224, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia A Munro, PhD
Johns Hopkins School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2023
First Posted
April 3, 2023
Study Start
March 1, 2023
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- At time of publication of primary results or within 9 months of database lock, whichever comes first. No end data for data availability has been determined at this time.
- Access Criteria
- Researchers at academic institutions are eligible.
Study investigators are committed to resource sharing, according to NIH policy. At the conclusion of the study, after the final freeze to the database, a public use database will be created and made available along with specifications for its use. Johns Hopkins University will share anonymized genomic sequence data by depositing these data in the database of Genotypes and Phenotypes (dbGaP) (a controlled-access database funded by NIH). In addition, the investigators will share data from biosamples (saliva and blood samples), including genotype data, at the time of publication of the primary results or within 9 months of database lock, whichever comes first. These data will be shared via the Alzheimer's Clinical Trials Consortium (ACTC), and/or the National Alzheimer's Coordinating Center (NACC).