- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04601038
Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X) (CORT-X)
July 6, 2023 updated by: Johns Hopkins University
Phase II Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)
CORT-X will examine if mitigation of stress-mediated pathogenesis of Alzheimer's disease (AD) is a feasible target for intervention in individuals at risk for this disease.
This single-site (Baltimore, Maryland) phase II clinical trial is a 2-week, randomized, 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 due to family history, genetics, and/or subjective memory complaints.
All subjects will participate in a brief stressor (public speaking and mental arithmetic) and provide saliva samples so investigators can measure stress hormone response.
Then, following 2 weeks of treatment with placebo or CORT108297, in counterbalanced order, participants will complete cognitive tests assessing memory and executive function.
All study participants will receive CORT108297 and placebo over the course of this 10-week trial that requires 6 in-person study visits.
The primary aims will compare the effects of CORT108297 to placebo on cognitive test performance in individuals with MCI due to AD and in individuals at risk for AD, and describe the side effects of CORT108297 in study participants.
Secondary aims will identify subject characteristics that predict positive response to study drug.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cynthia A Munro, PhD
- Phone Number: 410-550-6271
- Email: cmunro@jhmi.edu
Study Contact Backup
- Name: Nicholas Bienko, MS
- Phone Number: 410-550-2036
- Email: nbienko1@jhmi.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Recruiting
- Johns Hopkins School of Medicine
-
Contact:
- Nick Bienko, MA
- Phone Number: 410-550-2036
- Email: nbienko1@jhmi.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Individuals must meet criteria for mild cognitive impairment due to Alzheimer's disease according to National Institute on Aging (NIA)/Alzheimer's Association recommendations OR be cognitively normal based on clinical and cognitive assessment in the Enrollment Visit and have at least one of the following risk factors for AD:
- Known to have at least 1 apolipoprotein E (APOE) ε4 allele;
- Subjective cognitive concerns with a T score < 40 on the Multifactorial Memory Questionnaire Satisfaction Scale23;
- A first-degree relative with dementia.
Inclusion Criteria for all subjects:
- At least 55 years of age;
- Body mass index >17 and <30;
- Post-menopausal (if female)
- Non-smoker;
- Availability of a study partner who has frequent contact with the subject (10+ hours/week in person and by telephone), and is able to provide an independent evaluation of functioning;
- Native English speaker;
- Good general health with no disease expected to interfere with the study;
- Willing and able to participate for the duration of the study.
Exclusion Criteria for all subjects:
- Participation in a therapeutic clinical trial at any time during the study;
- Abnormal corrected QT interval using Bazett's formula (QTcB; defined as > 450 ms for men and > 470 ms for women) as determined on ECG;
- Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities, including lacunes in critical memory structures including the hippocampus and parahippocampal cortex;
- Major depression, bipolar disorder within the past 1 year;
- History of alcohol or drug dependence;
- Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol;
- 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;
- Treatment within the last six months with antidepressants, neuroleptics, sedative hypnotics, or glucocorticoids;
- Treatment within the last six months with medications metabolized by the CYP2C9 or CYP2C19 enzymes, most notably clopidogrel and proton pump inhibitors;
- Concurrent use of a CYP3A inhibitor, including grapefruit juice, and St. John's Wort;
- Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the PI.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: MCI
Individuals with mild cognitive impairment due to Alzheimer's disease
|
120mg of a selective glucocorticoid receptor antagonist, taken as 2 tablets daily for 2 weeks
Placebo taken as 2 tablets daily for 2 weeks
|
Other: Cognitively Normal
Individuals who are cognitively normal but who are at risk for Alzheimer's disease
|
120mg of a selective glucocorticoid receptor antagonist, taken as 2 tablets daily for 2 weeks
Placebo taken as 2 tablets daily for 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Memory as assessed by pattern separation task performance after 2 weeks of treatment with CORT108297
Time Frame: After 2 weeks of treatment
|
Percent of correct responses to the "lure" items on the pattern separation task, with 100% indicating a perfect score
|
After 2 weeks of treatment
|
Memory as assessed by the Hopkins Verbal Learning Test-Revised Edition (HVLT-R) after 2 weeks of treatment with CORT108297
Time Frame: After 2 weeks of treatment
|
Total number of words recalled in trials 1, 2, 3, and the delayed recall trial of the HVLT-R, with scores ranging from 0 (no words recalled) to 48 (all 12 words recalled after each of the trials)
|
After 2 weeks of treatment
|
Executive functioning as assessed by the Trail Making Test (TMT), part B after 2 weeks of treatment with CORT108297
Time Frame: After 2 weeks of treatment
|
Number of seconds required to complete part B of the TMT, with lower scores indicating better performance
|
After 2 weeks of treatment
|
Executive functioning as assessed by the Digit Span Task (digit span backwards) after 2 weeks of treatment with CORT108297
Time Frame: After 2 weeks of treatment
|
Total number of correct responses on the backwards trials of the Digit Span Task, with scores ranging from 0 (no trials correct) to 14 (perfect score)
|
After 2 weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cynthia A Munro, PhD, Johns Hopkins School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 28, 2021
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
October 19, 2020
First Submitted That Met QC Criteria
October 19, 2020
First Posted (Actual)
October 23, 2020
Study Record Updates
Last Update Posted (Actual)
July 7, 2023
Last Update Submitted That Met QC Criteria
July 6, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00227116
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on CORT108297
-
VA Office of Research and DevelopmentRecruiting