Encephalopathy, Radiation Effect
Conditions
Keywords
Radiation encephalopathy, Amantadine, Gocovri
Brief 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.
Interventions
DRUGGocovri (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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals ≥ 18 years of age. * Individuals with caregivers who are able to complete survey assessments for this study. * Prior brain radiation treatment. * Evidence of moderate-severe confluent white matter hyperintensity on MRI brain scan as judged by neuroradiology impression 0-5 years prior to enrollment. * DRS \> 6 * The effects of Gocovri on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (e.g. hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; female subjects will be required to demonstrate a negative urine pregnancy test prior to study entry and subjects who are lactating should be excluded.
Exclusion criteria
* Pregnant or breastfeeding. * Patients with growing brain lesions or those requiring escalating doses of tumor-directed treatment.. * Patients requiring doses of Dexamethasone higher than 4 mg or escalating doses of Dexamethasone * Patients taking Amantadine or with prior usage of Amantadine. * Patients taking other dopaminergic, GABAergic, glutamatergic, or noradrenergic drugs. * Patients with a history of suicidality and depression. * Patients with end stage renal disease (creatinine clearance less than 15 mL/min/1.73 m2).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the level of disability as measured by the Disability Rating Scale(DRS) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognition based on the MoCA test. | 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. |
| Change in 18F-FPEB avidity on PET/CT. | Baseline - 24 weeks. | — |
Countries
United States
Contacts
CONTACTRajiv S Magge, MD
PRINCIPAL_INVESTIGATORRajiv S Magge, MD
Weill Medical College of Cornell University
Outcome results
None listed