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Corticosteroid

CORT108297 for Alzheimer's Disease (CORT-X Trial)

Phase 2
Recruiting
Led By Cynthia A. Munro, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Native English speaker
At least 55 years of age
Must not have
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
Concurrent use of a CYP3A inhibitor, including grapefruit juice, and St. John's Wort
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 2 weeks of treatment

Summary

This trial is examining if a stress-mediation pathogenesis of Alzheimer's disease is a possible target for intervention in individuals at risk for the disease. The study is a 2-week, 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.

Who is the study for?
This trial is for adults with mild cognitive impairment due to Alzheimer's or at risk for it because of family history, genetics, or memory concerns. Participants must be non-smokers in good health, not on certain medications, and have a study partner available. They cannot join if they have other significant illnesses, are taking conflicting drugs like CYP3A inhibitors (including grapefruit juice), or have had recent surgery.
What is being tested?
CORT-X is testing CORT108297 against a placebo to see if it can improve memory and executive function after stress in people with mild cognitive impairment from Alzheimer's or those at risk. It's a two-week treatment within a 10-week trial involving six visits where everyone gets both the drug and placebo at different times.
What are the potential side effects?
While the specific side effects of CORT108297 aren't detailed here, participants will be monitored for any adverse reactions during the trial as they take this medication that targets stress-related pathways potentially involved in Alzheimer’s disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a native English speaker.
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I am 55 years old or older.
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I am a woman and have gone through menopause.
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My parent, sibling, or child has dementia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have major neurological conditions except possible early Alzheimer's.
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I am not taking CYP3A inhibitors or consuming grapefruit juice and St. John's Wort.
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I have not had any major surgery in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 2 weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 2 weeks of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Executive functioning as assessed by the Digit Span Task (digit span backwards) after 2 weeks of treatment with CORT108297
Executive functioning as assessed by the Trail Making Test (TMT), part B after 2 weeks of treatment with CORT108297
Memory as assessed by pattern separation task performance after 2 weeks of treatment with CORT108297
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: MCIExperimental Treatment2 Interventions
Individuals with mild cognitive impairment due to Alzheimer's disease
Group II: Cognitively NormalExperimental Treatment2 Interventions
Individuals who are cognitively normal but who are at risk for Alzheimer's disease
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Private Philanthropic FundsUNKNOWN
3 Previous Clinical Trials
95 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,323 Previous Clinical Trials
14,874,248 Total Patients Enrolled
Cynthia A. Munro, PhDPrincipal InvestigatorJohns Hopkins School of Medicine

Media Library

CORT108297 (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04601038 — Phase 2
Mild Cognitive Impairment Research Study Groups: MCI, Cognitively Normal
Mild Cognitive Impairment Clinical Trial 2023: CORT108297 Highlights & Side Effects. Trial Name: NCT04601038 — Phase 2
CORT108297 (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04601038 — Phase 2
~8 spots leftby Jun 2025
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