Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
At least 55 years of age;
Disqualifiers
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;
Trial design
Design model
Crossover
Treatments tested in this trial
CORT108297
Drug120mg of a selective glucocorticoid receptor antagonist, taken as 2 tablets daily for 2 weeks
Placebo
DrugPlacebo taken as 2 tablets daily for 2 weeks
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: MCIOther 2 interventions
Group B: Cognitively NormalOther 2 interventions
Trial outcomes
Primary outcomes
1
Memory as assessed by pattern separation task performance after 2 weeks of treatment with CORT108297
Percent of correct responses to the "lure" items on the pattern separation task, with 100% indicating a perfect score
Time frame
After 2 weeks of treatment2
Memory as assessed by the Hopkins Verbal Learning Test-Revised Edition (HVLT-R) after 2 weeks of treatment with CORT108297
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)
Time frame
After 2 weeks of treatment3
Executive functioning as assessed by the Trail Making Test (TMT), part B after 2 weeks of treatment with CORT108297
Number of seconds required to complete part B of the TMT, with lower scores indicating better performance
Time frame
After 2 weeks of treatment4
Executive functioning as assessed by the Digit Span Task (digit span backwards) after 2 weeks of treatment with CORT108297
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)
Time frame
After 2 weeks of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Private Philanthropic Funds
Collaborator
Source ClinicalTrials.gov