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

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ClinicalTrials.gov Identifier: NCT04601038
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : March 8, 2023
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer Disease Memory Impairment Drug: CORT108297 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
MCI
Individuals with mild cognitive impairment due to Alzheimer's disease
 Drug: CORT108297
120mg of a selective glucocorticoid receptor antagonist, taken as 2 tablets daily for 2 weeks

Drug: Placebo
Placebo taken as 2 tablets daily for 2 weeks
Cognitively Normal
Individuals who are cognitively normal but who are at risk for Alzheimer's disease
 Drug: CORT108297
120mg of a selective glucocorticoid receptor antagonist, taken as 2 tablets daily for 2 weeks

Drug: Placebo
Placebo taken as 2 tablets daily for 2 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Memory as assessed by pattern separation task performance after 2 weeks of treatment with CORT108297 [ Time Frame: After 2 weeks of treatment ]
    Percent of correct responses to the "lure" items on the pattern separation task, with 100% indicating a perfect score

  2. Memory as assessed by the Hopkins Verbal Learning Test-Revised Edition (HVLT-R) after 2 weeks of treatment with CORT108297 [ Time Frame: 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)

  3. Executive functioning as assessed by the Trail Making Test (TMT), part B after 2 weeks of treatment with CORT108297 [ Time Frame: After 2 weeks of treatment ]
    Number of seconds required to complete part B of the TMT, with lower scores indicating better performance

  4. Executive functioning as assessed by the Digit Span Task (digit span backwards) after 2 weeks of treatment with CORT108297 [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Individuals must meet criteria for mild cognitive impairment due to Alzheimer's disease according to National Institute on Aging (NIA)/Alzheimer's Association recommendations OR be cognitively normal based on clinical and cognitive assessment in the Enrollment Visit and have at least one of the following risk factors for AD:

  • Known to have at least 1 apolipoprotein E (APOE) ε4 allele;
  • Subjective cognitive concerns with a T score < 40 on the Multifactorial Memory Questionnaire Satisfaction Scale23;
  • A first-degree relative with dementia.

Inclusion Criteria for all subjects:

  • At least 55 years of age;
  • Body mass index >17 and <30;
  • Post-menopausal (if female)
  • Non-smoker;
  • Availability of a study partner who has frequent contact with the subject (10+ hours/week in person and by telephone), and is able to provide an independent evaluation of functioning;
  • Native English speaker;
  • Good general health with no disease expected to interfere with the study;
  • Willing and able to participate for the duration of the study.

Exclusion Criteria for all subjects:

  • Participation in a therapeutic clinical trial at any time during the study;
  • Abnormal corrected QT interval using Bazett's formula (QTcB; defined as > 450 ms for men and > 470 ms for women) as determined on ECG;
  • 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;
  • Major depression, bipolar disorder within the past 1 year;
  • History of alcohol or drug dependence;
  • Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol;
  • General surgery within the last 3 months;
  • Sensory impairment (poor vision or hearing) significant enough to interfere with ability to provide valid cognitive test data;
  • Treatment within the last six months with antidepressants, neuroleptics, sedative hypnotics, or glucocorticoids;
  • Treatment within the last six months with medications metabolized by the CYP2C9 or CYP2C19 enzymes, most notably clopidogrel and proton pump inhibitors;
  • Concurrent use of a CYP3A inhibitor, including grapefruit juice, and St. John's Wort;
  • Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the PI.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601038


Contacts
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Contact: Nicholas Bienko, MS 410-550-2036 nbienko1@jhmi.edu
Contact: Cynthia A Munro, PhD 410-550-6271 cmunro@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21224
Contact: Nick Bienko, MA    410-550-2036    nbienko1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Cynthia A Munro, PhD Johns Hopkins School of Medicine
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04601038    
Other Study ID Numbers: IRB00227116
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Stress
Memory loss
Dementia
 Alzheimer's disease
Cognitive
Impairment
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders