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CORT-X

RecruitingPhase 2

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

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

Lead sponsor

Johns Hopkins University

Asset

CORT108297

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•MCI due to AD

Primary endpoints

•Memory•Executive functioning

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIRB00227116

NCT IDNCT04601038

Timeline

Milestones

Study first posted2020-10-23actual

Study start2021-06-28actual

Last update posted2026-07-13actual

Primary completion2027-11-30estimated

Study completion2028-01-01estimated

Assets

Drug assets

CORT108297

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

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 Scale;

•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;

•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 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;

•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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Memory

Executive function / language

Other (unclassified)

Memory

2 endpoints

Primary/protocol endpoint

Memory as assessed by pattern separation task performance after 2 weeks of treatment with CORT108297

Time frame:After 2 weeks of treatment

ratio, descriptive

Primary/protocol endpoint

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

event count, event

Executive function / language

1 endpoint

Primary/protocol endpoint

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

event count, event

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

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

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.