NCT07125222

Use of Gocovri to Improve Disability Due to Radiation Encephalopathy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to assess the effect of Gocovri (extended-release amantidine) to improve disability as assessed by the disability rating scale (DRS) and cognition as assessed by the Montreal Cognitive Assessment (MoCA) test in patients with radiation encephalopathy.

Detailed description

This is a prospective study to assess the effect of Gocovri (extended-release amantidine) on disability and cognition in patients with radiation encephalopathy. Patients with radiation encephalopathy will be seen in the office, and both clinical and short structured neuropsychological assessments will be collected longitudinally as medication adjustments are performed over time. The investigators will also measure functional glutamate activity in these subjects through use of F-FPEB PET/CT, which identifies mGluR5 expression in the brain. This imaging tracer serves as a surrogate for neurodegeneration in other conditions, such as Parkinson's Disease.

Conditions

• Radiation Encephalopathy

Interventions

Type	Name	Description
DRUG	Gocovri (extended-release amantidine)	Gocovri is extended release formulation of amantidine. Starting on Day 1, patients will start Gocovri 137mg daily. If there is no dose-limited event after 28 days, the dose will be increased to 274mg daily which will become the new standard dose for the remaining 20 weeks of the patient's participation in the study.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study