Clinical Trials Directory

Trials / Completed

CompletedNCT03475186

Testing Ramipril to Prevent Memory Loss in People With Glioblastoma

A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
75 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

This is a pilot study of an oral drug Ramipril to prevent cognitive decline in glioblastoma patients receiving partial brain radiation and concurrent and adjuvant temozolomide . Ramipril will be titrated to the highest tolerable dose during chemoradiation (2.5-5 mg). Once this dose is determined, the patient will continue at this dose for 4 months after the completion of chemoradiation. Patients will be followed until 5 months post chemoradiation for compliance, toxicity, cognitive decline and participant reported outcomes (PRO).

Conditions

Interventions

TypeNameDescription
DRUGRamipril2.5 - 5 mg oral, 1x daily for 22 weeks

Timeline

Start date
2019-03-25
Primary completion
2025-03-25
Completion
2025-03-25
First posted
2018-03-23
Last updated
2026-03-13
Results posted
2026-03-13

Locations

423 sites across 2 countries: United States, Guam

Regulatory

Source: ClinicalTrials.gov record NCT03475186. Inclusion in this directory is not an endorsement.