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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether CORT108297 helps memory and thinking after stress and checks its side effects. It is for adults age 55 or older with mild memory and thinking problems due to Alzheimer's disease, or normal thinking skills but a higher risk of Alzheimer's. The study lasts 10 weeks, includes 6 visits in Baltimore, and gives each person both the study drug and a placebo (a pill with no study drug).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have mild memory and thinking problems due to Alzheimer's, OR have normal thinking skills plus an APOE ε4 gene linked to Alzheimer's risk, memory concerns with a questionnaire score below 40, or a parent, sibling, or child with dementia.
  • Be at least 55 years old.
  • Have a body mass index (BMI, a measure of weight compared with height) above 17 and below 30.
  • If female, have gone through menopause.
  • Do not smoke.
  • Have a study partner with at least 10 hours of contact each week, in person and by phone, who can report on your daily skills.
  • Speak English fluently.
  • Be in good general health, with no illness that would interfere, and be willing and able to finish the study.

Who can't join

  • Be in another trial testing a treatment during this study.
  • Have an abnormal heart timing measure on an ECG heart test: QTcB above 450 milliseconds for men or 470 for women.
  • Have a major brain or nerve disease other than suspected early Alzheimer's, or a serious head injury with lasting problems or known changes in brain structure.
  • Have had bipolar disorder in the past year, or any history of alcohol or drug dependence.
  • Have a serious illness or unstable health problem that could make study tasks difficult, or have had general surgery in the past 3 months.
  • Have vision or hearing problems that would affect memory and thinking test results.
  • In the past 6 months, have taken antipsychotic drugs, sleep or sedating drugs, glucocorticoids (steroid medicines), or drugs processed by liver enzymes called CYP2C9 or CYP2C19, especially clopidogrel or proton pump inhibitors for stomach acid.
  • Currently use a CYP3A inhibitor (something that slows a drug-processing enzyme), including grapefruit juice, or St. John's wort. The lead researcher may consider exceptions to these rules case by case.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

MD