Start: June 2021
End: January 1, 2024
What Is This Study About?
CORT108297 is an FDA-approved drug used to manage the neural and hormonal responses to stress. This study will test whether the drug can improve memory and thinking in people who have mild cognitive impairment (MCI) due to Alzheimer's or who are at risk for developing Alzheimer's due to family history, genetics, or memory problems. Participants will be randomly assigned to take three tablets of either the study drug or a placebo, every day for two weeks. Over 10 weeks, each group will alternate between receiving the study drug or placebo, attend six study visits, and complete cognition and memory tests. After doing a brief, stressful activity, such as public speaking or mental arithmetic, participants will provide saliva samples to measure stress hormone response.
Do I Qualify To Participate in This Study?
Inclusion Criteria for Participants with MCI:
- Meet NIA-Alzheimer's Association diagnostic criteria for MCI due to Alzheimer's disease
Inclusion Criteria for Participants at Risk for Developing Alzheimer's Disease:
- Normal cognition based on clinical and cognitive assessment
- Have at least one of the following risk factors for Alzheimer's disease:
- Known to have at least one apolipoprotein E (APOE) epsilon 4 allele
- T-score <40 on the Multifactorial Memory Questionnaire Satisfaction Scale
- First-degree relative (mother, father, sister, or brother) with dementia
Inclusion Criteria for All Participants:
- Body mass index >17 and <30
- Post-menopausal, if female
- Availability of a study partner who:
- Has frequent contact with the participant (10+ hours/week in person and by telephone)
- Can provide information about the participant's functioning
- Native English speaker
- Good general health
Must NOT have:
- Participation in another clinical trial during the study
- Irregular heart rate, or arrhythmia, based on an electrocardiogram
- Any significant neurologic disease other than Alzheimer's disease
- History of significant head trauma resulting in a physical dysfunction (e.g., speech or walking problems) or known structural brain abnormalities
- Major depression or bipolar disorder within the past year
- History of alcohol or drug dependence
- General surgery within the last three months
- Any significant illness or unstable medical condition
- Uncorrected vision or hearing problems significant enough to interfere with the study
- Prohibited medications:
- Antidepressants, neuroleptics, sedative hypnotics, or glucocorticoids, within the last six months
- Any medications processed by the enzymes CYP2C9 or CYP2C19, such as clopidogrel and proton pump inhibitors, within the last six months
- CYP3A inhibitor medication or supplement, including grapefruit juice and St. John's Wort
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Nicholas Bienko, MA
Cynthia A Munro, PhD
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Johns Hopkins University
Source: ClinicalTrials.gov ID: NCT04601038