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Stress Response Testing for Alzheimer's Risk (Stress-AD Trial)
N/A
Recruiting
Led By Cynthia A Munro, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to visit 3 (up to 2 years)
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate how genetics and the response to stress affect cognitive decline in people with mild cognitive impairment. Participants will provide samples and take tests over 2 years.
Who is the study for?
This trial is for English-speaking individuals aged 60 or older with mild cognitive impairment (MCI), who can consent to the study and have a 'study partner' available. They must be able to return for follow-up after two years, have a BMI between 17 and 30, and meet specific clinical criteria for MCI.
What is being tested?
The study uses the Trier Social Stress Test to understand if stress hormones predict cognitive decline in those at risk for Alzheimer's. It explores how genes linked to Alzheimer's affect this relationship and whether they forecast changes in cognition and biomarkers over two years.
What are the potential side effects?
While not explicitly listed, potential side effects may include stress from the social test procedure, discomfort from blood draws, possible anxiety during memory tests, or emotional responses when discussing daily functioning.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to visit 3 (up to 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to visit 3 (up to 2 years)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in mean executive test composite score
Change in mean memory test composite score
Secondary study objectives
Change (in nanogram per liter; ng/L) in level of neurofilament light (NF-L)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Trier Social Stress TestExperimental Treatment1 Intervention
All participants in the study will get undergo the same stress procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trier Social Stress Test
2017
N/A
~300
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,802 Previous Clinical Trials
28,193,741 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,546 Total Patients Enrolled
Cynthia A Munro, PhDPrincipal InvestigatorJohns Hopkins School of Medicine
1 Previous Clinical Trials
52 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a native English speaker with Mild Cognitive Impairment.I have MCI and no history of major psychiatric illnesses.I have mild cognitive impairment and my BMI is between 17 and 30.I have MCI and have never had a severe head injury, stroke, or seizure.I have mild cognitive impairment and haven't had any major surgery in the last 3 months.My study partner is at least 21 years old.My study partner is willing to answer questions about my condition.I am 60 or older with Mild Cognitive Impairment.I have MCI without any neurological disorders like Parkinson's or Huntington's.I have MCI and no history of immune disorders like MS.I haven't taken antidepressants, sedatives, or similar drugs in the last 6 months.My study partner and I can commit to a 2-year follow-up visit.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Trier Social Stress Test
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.