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

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Cynthia A Munro, PhD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Trials

4

Recruited

150+