Ramipril for Memory Loss in Glioblastoma Patients

Recruiting at 422 trial locations

Overseen By Karen Craver, MT, MHA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Must not be taking: Ace inhibitors, Angiotensin blockers, Cognition enhancers

Disqualifiers: Renal insufficiency, Recurrent gliomas, HIV, 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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Glenn Lesser, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation

Participants receive Ramipril titrated to the highest tolerable dose during chemoradiation

3 weeks

Weekly visits for dose titration

Post-Chemoradiation Treatment

Participants continue Ramipril at the determined dose for 4 months post-chemoradiation

16 weeks

Monthly visits for monitoring

Follow-up

Participants are monitored for compliance, toxicity, cognitive decline, and participant-reported outcomes

5 months post-chemoradiation

What Are the Treatments Tested in This Trial?

Interventions

• Ramipril

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.

How Is the Trial Designed?

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 United States, Canada, European Union, India for the following indications:

Approved in United States as Altace for:

• High blood pressure
• Heart failure
• Diabetic kidney disease
• Prevention of heart attack, stroke, or cardiovascular death in high-risk patients

Approved in Canada as Altace for:

• High blood pressure
• Heart failure
• Diabetic kidney disease

Approved in European Union as Ramipril for:

• High blood pressure
• Heart failure
• Diabetic kidney disease
• Prevention of heart attack, stroke, or cardiovascular death in high-risk patients

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+