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Corticosteroid
CORT108297 for Alzheimer's Disease (CORT-X Trial)
Phase 2
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
Native English speaker
At least 55 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 2 weeks of treatment
Awards & highlights
CORT-X Trial Summary
This trial is examining if a stress-mediation pathogenesis of Alzheimer's disease is a possible target for intervention in individuals at risk for the disease. The study is a 2-week, placebo-controlled crossover study of the effects of the selective glucocorticoid receptor antagonist, CORT108297, on cognitive test performance in 26 individuals with mild cognitive impairment (MCI) due to AD and in 26 cognitively normal individuals with an increased risk for AD.
Who is the study for?
This trial is for adults with mild cognitive impairment due to Alzheimer's or at risk for it because of family history, genetics, or memory concerns. Participants must be non-smokers in good health, not on certain medications, and have a study partner available. They cannot join if they have other significant illnesses, are taking conflicting drugs like CYP3A inhibitors (including grapefruit juice), or have had recent surgery.Check my eligibility
What is being tested?
CORT-X is testing CORT108297 against a placebo to see if it can improve memory and executive function after stress in people with mild cognitive impairment from Alzheimer's or those at risk. It's a two-week treatment within a 10-week trial involving six visits where everyone gets both the drug and placebo at different times.See study design
What are the potential side effects?
While the specific side effects of CORT108297 aren't detailed here, participants will be monitored for any adverse reactions during the trial as they take this medication that targets stress-related pathways potentially involved in Alzheimer’s disease.
CORT-X Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a native English speaker.
Select...
I am 55 years old or older.
Select...
I am a woman and have gone through menopause.
Select...
My parent, sibling, or child has dementia.
CORT-X Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 2 weeks of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 2 weeks of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Executive functioning as assessed by the Digit Span Task (digit span backwards) after 2 weeks of treatment with CORT108297
Executive functioning as assessed by the Trail Making Test (TMT), part B after 2 weeks of treatment with CORT108297
Memory as assessed by pattern separation task performance after 2 weeks of treatment with CORT108297
+1 moreCORT-X Trial Design
2Treatment groups
Experimental Treatment
Group I: MCIExperimental Treatment2 Interventions
Individuals with mild cognitive impairment due to Alzheimer's disease
Group II: Cognitively NormalExperimental Treatment2 Interventions
Individuals who are cognitively normal but who are at risk for Alzheimer's disease
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,445 Total Patients Enrolled
Cynthia A. Munro, PhDPrincipal InvestigatorJohns Hopkins School of Medicine
Cynthia A Munro, PhDPrincipal InvestigatorJohns Hopkins School of Medicine
1 Previous Clinical Trials
240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have early signs of memory problems related to Alzheimer's disease or be mentally sharp, but have at least one risk factor for Alzheimer's disease.You have a history of being dependent on alcohol or drugs.I am a native English speaker.Your vision or hearing problems make it hard for you to take cognitive tests accurately.I am 55 years old or older.I have not taken antidepressants, sedatives, or steroids in the last 6 months.Your heart's electrical activity, as measured by a test called ECG, shows abnormal QT interval. For men, the QT interval is longer than 450 milliseconds, and for women, it's longer than 470 milliseconds.I am in good health with no conditions that could affect the study.I do not have major neurological conditions except possible early Alzheimer's.You have had major depression or bipolar disorder in the past year.I haven't taken drugs like clopidogrel or heartburn meds in the last 6 months.You do not smoke cigarettes.I am a woman and have gone through menopause.You cannot have participated in another medical study while this study is happening.I have mild memory issues due to Alzheimer's or am at risk due to genetics, memory concerns, or family history.I am not taking CYP3A inhibitors or consuming grapefruit juice and St. John's Wort.I have someone who can report on my health for 10+ hours a week.I have not had any major surgery in the last 3 months.I do not have any major health issues that would prevent me from following the study's requirements.Your body mass index is between 17 and 30.My parent, sibling, or child has dementia.
Research Study Groups:
This trial has the following groups:- Group 1: MCI
- Group 2: Cognitively Normal
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is this trial recruiting?
"Affirmative. Clinicaltrials.gov attests that this medical trial, which was initially unveiled on June 28th 2021, is actively searching for participants. About 52 individuals are expected to enrol from 2 separate locations."
Answered by AI
Are there any available openings to join this research initiative?
"Indeed, clinicaltrials.gov reflects that this medical experiment is still recruiting patients to participate. It was initially made available on June 28th 2021 and the information had been refreshed as of June 21st 2022."
Answered by AI
Has this treatment been officially sanctioned by the US Food and Drug Administration?
"Due to the lack of available clinical evidence demonstrating efficacy, our team at Power has assigned a safety score of 2 out of 3. This is in concordance with Phase 2 trial standards which confirm some data backing safety but no confirmation regarding effectiveness."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
Johns Hopkins
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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