Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X) (CORT-X)
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ClinicalTrials.gov Identifier: NCT04601038 |
Recruitment Status :
Recruiting
First Posted : October 23, 2020
Last Update Posted : March 8, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mild Cognitive Impairment Alzheimer Disease Memory Impairment | Drug: CORT108297 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X) |
Actual Study Start Date : | June 28, 2021 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | January 1, 2024 |

Arm | Intervention/treatment |
---|---|
MCI
Individuals with mild cognitive impairment due to Alzheimer's disease
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Drug: CORT108297
120mg of a selective glucocorticoid receptor antagonist, taken as 2 tablets daily for 2 weeks Drug: Placebo Placebo taken as 2 tablets daily for 2 weeks |
Cognitively Normal
Individuals who are cognitively normal but who are at risk for Alzheimer's disease
|
Drug: CORT108297
120mg of a selective glucocorticoid receptor antagonist, taken as 2 tablets daily for 2 weeks Drug: Placebo Placebo taken as 2 tablets daily for 2 weeks |
- 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
- 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)
- 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
- 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)

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601038
Contact: Nicholas Bienko, MS | 410-550-2036 | nbienko1@jhmi.edu | |
Contact: Cynthia A Munro, PhD | 410-550-6271 | cmunro@jhmi.edu |
United States, Maryland | |
Johns Hopkins School of Medicine | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Nick Bienko, MA 410-550-2036 nbienko1@jhmi.edu |
Principal Investigator: | Cynthia A Munro, PhD | Johns Hopkins School of Medicine |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT04601038 |
Other Study ID Numbers: |
IRB00227116 |
First Posted: | October 23, 2020 Key Record Dates |
Last Update Posted: | March 8, 2023 |
Last Verified: | March 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Stress Memory loss Dementia |
Alzheimer's disease Cognitive Impairment |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |