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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT04601038
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • CORT108297 — DRUG
    120mg of a selective glucocorticoid receptor antagonist, taken as 2 tablets daily for 2 weeks
  • Placebo — DRUG
    Placebo taken as 2 tablets daily for 2 weeks

Study Details

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.

Key Dates

Start date
Jun 28, 2021
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Other: MCI
    Individuals with mild cognitive impairment due to Alzheimer's disease
  • Other: Cognitively Normal
    Individuals who are cognitively normal but who are at risk for Alzheimer's disease

Primary Outcome Measure

Memory as assessed by pattern separation task performance after 2 weeks of treatment with CORT108297 [ Time Frame: After 2 weeks of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of MedicineBaltimoreMaryland21224
Nick Bienko, MA
[email protected]
410-550-2036

Find similar trials in Baltimore, MD

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Johns Hopkins School of Medicine· Baltimore, MD

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