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NCT04601038 · ClinicalTrials.gov registry record · Phase 2
Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)
A Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT04601038: Recruiting Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Johns Hopkins University.
NCT04601038 is a Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 52 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04601038, a Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Percent of correct responses to the "lure" items on the pattern separation task, with 100% indicating a perfect score
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CORT108297
Study Locations (1)
Maryland
- Johns Hopkins School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 2 |
What NCT04601038 shows while recruiting
NCT04601038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04601038 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04601038 about?
NCT04601038 is a clinical study titled "Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)". 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 t...
What is the current status of trial NCT04601038?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2021-06-28. Estimated completion is 2027-01-01.
What conditions does trial NCT04601038 study?
This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment, Memory Impairment.
What interventions are being tested in trial NCT04601038?
The interventions under investigation include: Placebo (DRUG), CORT108297 (DRUG).
Who is sponsoring clinical trial NCT04601038?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04601038 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04601038's enrollment target sits among peer trials
52 207th of 306 higher than 98 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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