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ACE Inhibitor

Ramipril for Memory Loss in Glioblastoma Patients

Phase 2

Waitlist Available

Led By Michael D Chan, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically proven diagnosis of glioblastoma or gliosarcoma (World Health Organization [WHO] grade IV) obtained at the time of a partial or gross total resection of the tumor. Patients who undergo a stereotactic needle biopsy alone are not eligible.

Study drug (Ramipril) must be given >= 21 days and ≤ 42 days after surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 10 weeks, 22 weeks

Awards & highlights

Study Summary

This trial is testing whether Ramipril can help cancer patients undergoing chemoradiation treatment by reducing memory loss. Patients will take the drug throughout treatment and for four months after. Memory will be assessed using neurocognitive tests.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Ramipril may cause a dry cough, dizziness due to low blood pressure, high potassium levels which can affect heart rhythm, kidney function changes, and swelling in parts of the body like lips or eyelids (angioedema).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I will start the study drug between 3 to 6 weeks after my surgery.

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My tumor is located in the upper part of my brain.

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I can take care of myself and am up and about more than half of my waking hours.

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I can complete tests in English.

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I had cancer before, but I finished treatment over 2 years ago and am now cancer-free.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline Neurocognitive Function at 10 weeks - Controlled Oral Word Association Test (COWA)

Change from Baseline Neurocognitive Function at 10 weeks - Hopkins Verbal Learning Test-Revised (HVLT-R)

Change from Baseline Neurocognitive Function at 10 weeks - Trail Making Test Part A and B (TMT A & B)

+2 more

Secondary outcome measures

Determine Presence of Apolipoprotein Epsilon (ApoE)

Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20)

Efficacy of neurocognitive function in surviving patients- COWA

+6 more

Side effects data

From 2009 Phase 4 trial • 252 Patients • NCT00391846

Cardiac Failure

Myocardial Infarction

Ventricular Tachycardia

Anaemia

Chronic Obstructive Pulmonary Disease

Syncope

Angina Pectoris

Artial Fibrillation

Dyspnoea

Hyperkalaemia

Pneumonia

Cerebral Infarction

Dyspepsia

Duodenal Ulcer Haemorrhage

Confusional State

Polymyalgia Rheumatica

Cerebrovascular Accident

Concussion

Endocarditis

Right Ventricular Failure

Hepatic Failure

Diverticulitis

Multi-Organ Failure

Aortic Stenosis

Intestinal Ischaemia

Spinal Fracture

Back Pain

Bladder Neoplasm

Blood Electrolytes Abnormal

Bradycardia

Muscular Weakness

Osteoarthritis

Angina Unstable

B-Cell Lymphoma

Bleeding Varicose Vein

Bronchitis

Carotid Artery Stenosis

Intervertebral Disc Compression

Pulmonary Odema

Respiratory Tract Infection Viral

Septic Shock

Peripheral Ischaemia

100%

80%

60%

40%

20%

Study treatment Arm

Guided by NT-proBNP

Not Guided by NT-proBNP

Trial Design

1Treatment groups

Experimental Treatment

Group I: RamiprilExperimental Treatment1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ramipril

2005

Completed Phase 4

~70860

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,239 Previous Clinical Trials

1,004,108 Total Patients Enrolled

10 Trials studying Glioblastoma

307 Patients Enrolled for Glioblastoma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,078 Total Patients Enrolled

322 Trials studying Glioblastoma

23,040 Patients Enrolled for Glioblastoma

Michael D Chan, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Ramipril (ACE Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03475186 — Phase 2

Glioblastoma Research Study Groups: Ramipril

Glioblastoma Clinical Trial 2023: Ramipril Highlights & Side Effects. Trial Name: NCT03475186 — Phase 2

Ramipril (ACE Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03475186 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being given the chance to participate in this research?

"In order to properly conduct this trial, 75 individuals who meet the pre-determined eligibility requirements are required. These potential participants can be found at Ascension Saint Joseph Hospital in Tawas City, Michigan and Lewis Cancer and Research Pavilion at Saint Joseph's/Candler in Savannah, Georgia among other locations."

Answered by AI

What are some common conditions that Ramipril is known to treat?

"Ramipril can be used to effectively manage heart failure and diabetic nephropathy when both component drugs are administered simultaneously."

Answered by AI

Are there any life-threatening risks associated with taking Ramipril?

"Ramipril's safety is based on Phase 2 trial data, meaning that while there are some studies supporting its safety, none have been done to test if it is effective. Our team at Power gave it a score of 2."

Answered by AI

What are the goals of this particular clinical trial?

"The purpose of this 10-week study is to investigate changes in neurocognitive function, as measured by the COWA test. Additional objectives include estimating time of neurocognitive decline using the HVLT-R test and determining the presence of ApoE via PCR blood testing. Finally, researchers will compare TMT A & B results between groups at study end to assess efficacy of neurocognitive function in surviving patients."

Answered by AI

How many places are managing this trial?

"At Ascension Saint Joseph Hospital in Tawas City, Lewis Cancer and Research Pavilion at Saint Joseph's/Candler in Savannah, Prisma Health Cancer Institute - Seneca in Seneca, and 100 other locations medical professionals are running this study."

Answered by AI

Are people currently being recruited for this experiment?

"That is accurate. The clinicaltrials.gov website has information about the current status of this trial, which was originally posted on March 25th, 2019 and updated on August 30th, 2020. They are looking for 75 patients to participate at 100 different locations."

Answered by AI

What other pharmaceutical studies has Ramipril been involved in?

"The initial study for ramipril was completed in 2015 at VA Medical Center. Since the publication of those findings, there have been 85 completed studies and 10 active clinical trials - several of which are based in Tawas City, Michigan."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Ramipril to Prevent Memory Loss in People With Glioblastoma

2019. "Testing Ramipril to Prevent Memory Loss in People With Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03475186.

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