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

Phase 2

Recruiting

• Conditions: Mild Cognitive Impairment; Alzheimer Disease; Memory Impairment
• Interventions: Drug: CORT108297; Drug: Placebo

• Registration Number: NCT04601038
• Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-23
• Study Start: 2021-06-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-06-30
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MCI	CORT108297	Individuals with mild cognitive impairment due to Alzheimer's disease
MCI	Placebo	Individuals with mild cognitive impairment due to Alzheimer's disease
Cognitively Normal	CORT108297	Individuals who are cognitively normal but who are at risk for Alzheimer's disease
Cognitively Normal	Placebo	Individuals who are cognitively normal but who are at risk for Alzheimer's disease

Primary Outcome Measures

Name	Time	Method
Memory as assessed by the Hopkins Verbal Learning Test-Revised Edition (HVLT-R) after 2 weeks of treatment with CORT108297	After 2 weeks of treatment	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)
Executive functioning as assessed by the Digit Span Task (digit span backwards) after 2 weeks of treatment with CORT108297	After 2 weeks of treatment	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)
Memory as assessed by pattern separation task performance after 2 weeks of treatment with CORT108297	After 2 weeks of treatment	Percent of correct responses to the "lure" items on the pattern separation task, with 100% indicating a perfect score
Executive functioning as assessed by the Trail Making Test (TMT), part B after 2 weeks of treatment with CORT108297	After 2 weeks of treatment	Number of seconds required to complete part B of the TMT, with lower scores indicating better performance

Trial Locations

Locations (1)

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States