Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)
Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
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.