Could blocking stress hormones shield the brain from Alzheimer's?

NCT ID NCT04601038

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests whether a drug called CORT108297, which blocks a stress hormone, can improve memory and thinking in people with mild cognitive impairment or those at risk for Alzheimer's disease. Participants take the drug or a placebo for two weeks, then complete memory and attention tests after a stressful task. The goal is to see if reducing stress-related brain changes can help protect cognitive function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CORT108297 (a stress hormone blocker)
What this could lead to
If it works, this could point toward a way to slow memory loss by blocking the harmful effects of stress on the brain.
What could go wrong
This is a small, early-phase trial with only 52 participants and a short 2-week treatment period. Results may not apply to everyone, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Scale; * 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; * Fluent 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; * 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 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.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction dementia Memory Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins School of Medicine

    RECRUITING

    Baltimore, Maryland, 21224, United States

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