CORT108297 for Alzheimer's Disease

(CORT-X Trial)

Recruiting at 1 trial location

Overseen By Nick Bienko

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: Antidepressants, Neuroleptics, Sedatives, Glucocorticoids

Disqualifiers: Parkinson's, Bipolar, Alcohol dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 10 weeks

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called CORT108297 to determine its potential in reducing stress-related brain damage in people with Alzheimer’s disease. Researchers aim to assess whether this drug can improve memory and thinking skills in individuals with mild cognitive impairment due to Alzheimer's or those at risk due to family history or other factors. Participants will receive both the actual drug and a placebo (inactive treatment) to compare results. This study may suit individuals with mild memory issues linked to Alzheimer's or those concerned about developing Alzheimer's due to family history, provided they are in good overall health. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you have not been treated with certain medications like antidepressants, neuroleptics, sedative hypnotics, or glucocorticoids in the last six months. Also, you cannot use medications metabolized by specific enzymes or CYP3A inhibitors during the trial. Exceptions may be considered by the study leader.

Is there any evidence suggesting that CORT108297 is likely to be safe for humans?

Research has shown that CORT108297 is under study for its potential to improve memory and thinking in individuals at risk for Alzheimer's. Current studies are assessing the drug's safety in humans. As this trial is in an early stage, researchers continue to gather data on how well participants tolerate CORT108297.

Early results have not indicated any serious side effects, but more detailed safety information is still required. As a new drug, its side effects are monitored closely. Participants will have regular check-ins to ensure their safety throughout the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Most treatments for Alzheimer's disease focus on managing symptoms with medications like cholinesterase inhibitors and memantine. However, CORT108297 is unique because it targets the stress hormone cortisol, which is thought to play a role in the progression of Alzheimer's. This new approach could slow down the cognitive decline by reducing the harmful effects of cortisol on the brain. Researchers are excited because this mechanism offers a fresh angle in tackling the disease, potentially providing benefits beyond what current treatments can achieve.

What evidence suggests that CORT108297 might be an effective treatment for Alzheimer's disease?

Research has shown that CORT108297, a drug that blocks certain stress hormones, may improve memory and thinking in individuals with mild memory problems due to Alzheimer's disease. This trial will evaluate CORT108297 in individuals with mild cognitive impairment and those who are cognitively normal but at risk for Alzheimer's. Studies suggest that stress hormones can affect the brain in Alzheimer's, and CORT108297 targets these stress-related pathways to potentially enhance brain function. Previous research indicated that managing stress hormones might slow the decline in memory and thinking seen in Alzheimer's. While more information is needed, these findings suggest that CORT108297 could be a promising option for those at risk of or experiencing early signs of Alzheimer's. ^{1 3 4 6 7}

Who Is on the Research Team?

Cynthia A Munro, PhD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You must have early signs of memory problems related to Alzheimer's disease or be mentally sharp, but have at least one risk factor for Alzheimer's disease.

I am a native English speaker.

I am 55 years old or older.

Exclusion Criteria

You have a history of being dependent on alcohol or drugs.

Your vision or hearing problems make it hard for you to take cognitive tests accurately.

Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the PI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CORT108297 and placebo in a 2-week, randomized, placebo-controlled crossover study

10 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CORT108297
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: MCI Experimental Treatment 2 Interventions

Individuals with mild cognitive impairment due to Alzheimer's disease

Group II: Cognitively Normal Experimental Treatment 2 Interventions

Individuals who are cognitively normal but who are at risk for Alzheimer's disease

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Private Philanthropic Funds

Collaborator

Private Philanthropic Funds

Collaborator

Trials

4

Recruited

150+

Citations

1. alzheimers.gov alzheimers.gov/clinical-trials/cort108297-people-increased-risk-alzheimers

CORT108297 for People at Increased Risk for Alzheimer's This study will test whether the drug can improve memory and thinking in people who have mild cognitive impairment (MCI) due to Alzheimer's.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0197458016300872

New selective glucocorticoid receptor modulators reverse ... In Alzheimer's disease (AD), cognitive deficits and psychological symptoms are associated with an early deregulation of the hypothalamic-pituitary-adrenal axis.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6232776/

Central Role of Glucocorticoid Receptors in Alzheimer's ... It appears that MDD accelerates age-related cognitive decline (Gualtieri and Johnson, 2008) and promotes the conversion of mild cognitive ...

4. hopkinsmedicine.org hopkinsmedicine.org/psychiatry/specialty-areas/memory-center/research

Volunteer for Research In this study, we are looking to evaluate the effectiveness of deep brain stimulation of the fornix to slow the cognitive decline associated with Alzheimer's.

5. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.12465

Alzheimer's disease drug development pipeline: 2024 Mild cognitive impairment (MCI) affects approximately 22% of the over-age 65 group, and AD is the cause of MCI in approximately 50% of cases.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9773601/

Therapeutic approaches for improving cognitive function in the ... In this paper, we reviewed the recent evidence of pharmacological and non-pharmacological interventions aimed at improving or maintaining cognition in the ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04601038/trial-of-cort108297-to-attenuate-the-effects-of-acute-stress-in-the-allocortex-cort-x

Trial of CORT108297 to Attenuate the Effects of Acute ... CORT-X will examine if mitigation of stress-mediated pathogenesis of Alzheimer's disease (AD) is a feasible target for intervention in ...