Ramipril for Memory Loss in Glioblastoma Patients

Recruiting at422 trial locations

Overseen by Michael D Chan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.

Research Team

Michael D Chan, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults with glioblastoma who are about to receive chemoradiation. They must have proper kidney, liver, and blood function, no prior use of ACE inhibitors or certain cancer treatments, and cannot be pregnant. Participants should not have other serious medical conditions that could interfere with the study.

Inclusion Criteria

I plan to undergo brain radiation and chemotherapy for 6 weeks, with the option to use Optune® after initial treatments.

My diagnosis of glioblastoma or gliosarcoma was confirmed through surgery, not just a needle biopsy.

I have a specific type of brain tumor and my doctor is trained to use the Optune device.

Exclusion Criteria

I haven't had certain cancer treatments like chemotherapy or radiation to specific areas.

I am not planning to receive extra cancer treatments besides standard radiation and temozolomide.

I haven't been in another drug study in the last 30 days.

Treatment Details

Interventions

• Ramipril (ACE Inhibitor)

Trial Overview The trial tests if Ramipril can prevent memory loss in glioblastoma patients undergoing chemoradiation. Patients will take Ramipril starting from 21 to 42 days after surgery until four months post-treatment while their memory is monitored using neurocognitive tests.

Participant Groups

Group I: Ramipril Experimental Treatment 1 Intervention

Ramipril will be taken once daily by mouth. It will be titrated during the first 3 weeks of chemoradiation to the highest tolerable dose (2.5-5 mg). This dose will be taken each day until 4 months post-chemoradiation treatment (22 weeks).

Ramipril is already approved in Canada, India for the following indications:

Approved in Canada as Altace for:

• High blood pressure
• Heart failure
• Diabetic kidney disease

Approved in India as Cardace for:

• High blood pressure
• Heart failure
• Diabetic kidney disease

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School