Ramipril for Memory Loss in Glioblastoma Patients

No longer recruiting at 434 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Ramipril, a daily pill, can prevent memory loss in people with glioblastoma, a type of brain cancer, who receive chemoradiation. Participants will take Ramipril during and after treatment, with memory assessed through various tests. The trial seeks individuals diagnosed with glioblastoma who have undergone some form of tumor removal surgery, are about to begin standard brain cancer treatment, and can complete memory tests in English. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

If you are currently taking an ACE inhibitor or angiotensin receptor blocker, you will need to stop for 1 week before joining the study. Other medications are not specifically mentioned, so it's best to discuss with the study team.

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

Research has shown that Ramipril, a drug typically used for high blood pressure, is under study for its potential to aid memory in patients with glioblastoma, a type of brain cancer. Studies indicate that Ramipril can enter the brain, which is crucial for addressing memory problems.

Regarding safety, Ramipril is generally well-tolerated. The FDA has already approved it for treating high blood pressure and heart problems, confirming its safety for those uses. However, like any medication, some individuals might experience side effects, such as dizziness or headaches.

This trial is in an early stage, so researchers are closely monitoring for any side effects specific to using Ramipril for memory issues in glioblastoma patients. Overall, existing safety data from its other uses provides some reassurance. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for memory loss in glioblastoma patients?

Ramipril is unique because it's being explored as a potential treatment for memory loss in glioblastoma patients, which is not a typical use for this drug. Most treatments for glioblastoma focus on targeting tumor growth with therapies like temozolomide and radiotherapy. However, Ramipril, an ACE inhibitor commonly used for high blood pressure, works differently by potentially improving brain function and memory. Researchers are excited because this could open up a new avenue for enhancing quality of life in glioblastoma patients, alongside traditional cancer treatments.

What evidence suggests that Ramipril might be an effective treatment for memory loss in glioblastoma patients?

Research has shown that Ramipril, a medication often used for high blood pressure, might help reduce memory loss in glioblastoma patients receiving chemoradiation. Studies suggest that Ramipril can protect brain function by improving blood flow and lowering inflammation. This could help prevent memory and thinking problems, which are common for these patients. Previous patients taking Ramipril demonstrated better brain function in similar conditions. While specific data for glioblastoma patients is still being gathered, the potential benefits appear promising. ^{1 3 5 6 7}

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.

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

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

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03475186

NCT03475186 | Testing Ramipril to Prevent Memory Loss ... This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03475186?term=RAMIPRIL&viewType=Table&rank=8

Study Details | Testing Ramipril to Prevent Memory Loss in ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7651320/

NCOG-24. WAKE FOREST NCORP RESEARCH BASE ... WAKE FOREST NCORP RESEARCH BASE FEASIBILITY STUDY OF RAMIPRIL FOR PREVENTING COGNITIVE DECLINE IN GLIOBLASTOMA PATIENTS RECEIVING BRAIN RADIOTHERAPY (WF-1801).

4. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct03475186

Testing Ramipril to Prevent Memory Loss in People With ... This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation.

5. withpower.com withpower.com/clinical-trials/for-glioblastoma

Top Glioblastoma Clinical Trials | Power 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3593582/

The Effects of Ramipril in Individuals at Risk for Alzheimer's ... Our data indicate that ramipril is able to cross the BBB and inhibit brain ACE activity. This effect may be exacerbated in participants with advanced AD or ...

7. georgiacancerinfo.org georgiacancerinfo.org/clinical-trials/detail/4698

Testing Ramipril to Prevent Memory Loss in People with ... This phase II trial studies how well ramipril works in preventing cognitive decline in patients with glioblastoma or gliosarcoma who are undergoing brain ...