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

Launched by JOHNS HOPKINS UNIVERSITY · Oct 19, 2020

Keywords

ClinConnect Summary

The CORT-X clinical trial is studying whether a medication called CORT108297 can help reduce the effects of stress on memory and thinking in people with mild cognitive impairment (MCI) related to Alzheimer’s disease, as well as those at risk for developing Alzheimer’s. This trial will take place over 10 weeks in Baltimore, Maryland, and will involve 52 participants in total—26 with MCI and 26 who are cognitively normal but have risk factors for Alzheimer’s, such as a family history of the disease or personal memory concerns. Participants will undergo a brief stress test and provide saliva samples to measure stress hormones. Then, they will receive either the study medication or a placebo (a fake treatment) for two weeks before switching to the other treatment.

To be eligible for this trial, participants must be at least 55 years old and meet specific criteria for MCI or have a known risk factor for Alzheimer’s. They should be in good health and able to attend six in-person visits during the study. Participants will be monitored for any side effects from the medication, and researchers will also look at factors that might predict who benefits most from the treatment. This trial is an important step in understanding how managing stress could impact cognitive health in those at risk for Alzheimer’s disease.

Gender

ALL

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;
• • 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.