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CORT108297 for Stress Effects in Mild Cognitive Impairment and Alzheimer's Risk

This study, called CORT-X, is looking at whether a drug called CORT108297 can help reduce the effects of stress that might contribute to Alzheimer's disease. CORT108297 is a selective glucocorticoid receptor antagonist, meaning it blocks certain stress hormones. You might be able to join if you are between 55 and older, and have mild cognitive impairment (MCI) due to Alzheimer's disease, or if you are cognitively normal but have a higher risk for Alzheimer's due to genetics (like having an APOE ε4 allele), family history, or memory concerns. The study will measure memory and thinking skills after two weeks of taking CORT108297 or a placebo. The current status of this study is unclear.

Study design
This is a Phase 2, single-site, randomized, placebo-controlled crossover study involving 52 participants.
What's involved
You would take CORT108297 or a placebo as two tablets daily for two weeks. You would also participate in a brief stressor (public speaking and mental arithmetic) and provide saliva samples.
Compensation
Not stated in the trial record.
Follow-up
Memory and executive function are assessed after two weeks of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04601038

Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)

Recruiting
PHASE2Ages 55+InterventionalTreatment
Johns Hopkins University
~52 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:CORT108297Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Memory as assessed by pattern separation task performance after 2 weeks of treatment with CORT108297
Measured over After 2 weeks of treatment
+3 more outcomes measured

Conditions

Mild Cognitive Impairment
Alzheimer Disease
Memory Impairment

Explore related trials

Alzheimer's DiseaseMild cognitive disorderAPOE GeneGlucocorticoid Receptor

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Cynthia A Munro, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins School of Medicine

Who to contact

Nicholas Bienko, MS
[email protected]
410-550-2036
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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;
Fluent 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

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;
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 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.

What this trial measures

  • Memory as assessed by pattern separation task performance after 2 weeks of treatment with CORT108297After 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 CORT108297After 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 CORT108297After 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 CORT108297After 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)