Weill Cornell Medicine
New York, 10065, United States
NCT Number: NCT07125222
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
New York, 10065, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline - 24 weeks.
The Disability Rating Scale (DRS) is a tool used to evaluate impairment, disability and handicap caused by brain injury. Scores range from 0 (No disability) to a maximum of 29 (indicating an extreme vegetative state).
Time frame: Baseline - 24 weeks.
The Montreal Cognitive Assessment (MoCA) is a brief screening tool to assess cognitive function and identify potential cognitive impairment. A score of 26-30 is considered normal, 18-25 as mild cognitive impairment, 10-17 as moderate cognitive impairment and below 10 as severe cognitive impairment.
Time frame: Baseline - 24 weeks.
Contact information is provided by the study sponsor or research team.
Weill Medical College of Cornell University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.