The purpose of this study is to determine if memantine is associated with greater improvement in declarative memory than placebo in patients receiving prescription corticosteroids. We will also examine if memantine is associated with greater improvement in working memory and other cognitive domains, mood symptoms, and functional quality of life than placebo.
The study is open to all English-speaking men and women aged 18-65 years. The patients must be taking at least 5 mg of prednisone or prednisolone for at least 6 months, with anticipated treatment for at least another 12 months.
The duration of the study is two 24-week cycles, with a week between cycles (for a total of approximately 50 weeks). During each cycle, the patient will have five clinic visits.
The patients will be given various mood, memory and health assessments during the study. The study also includes three MRI scans, so patients with metal implants close to the head or with claustrophobia will not be good candidates for the study. Participants must not have a history of mood disorders such as depression, bipolar disorder, and schizophrenia that is unrelated to corticosteroid use. Moreover, any conditions involving the central nervous system including multiple sclerosis, brain tumor, and seizures, and a lifetime history of drug and alcohol dependence are exclusions for the study. We encourage all patients to call the researchers to be screened for the study criteria.
We have pilot data suggesting that memantine (an NMDA receptor antagonist) improves declarative memory, a measure of hippocampal functioning, in people receiving prednisone therapy. Based on these data, a definitive trial of memantine is proposed in humans receiving corticosteroids. The study will examine declarative memory, explore other cognitive domains, hippocampal NAA and Glu levels, and brain region volumes.
Frequently Asked Questions
Q: What medication will I be given?
A: The study medication is a NMDA receptor antagonist called memantine. You will either receive this medication or a placebo (a pill that looks the same but has no active ingredients).
Q: Is compensation available for participation in the study?
A: Yes, patients will be paid for each visit in the study. Patients will also be paid for the successful completion of MRI scans.
Q: Is transportation available for the study appointments?
A: Yes. DART passes will be provided for each study visit to cover transportation costs.