Attenuation of Corticosteroid-Induced Hippocampal Changes

Study ID
STU 032011-007

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System

Contact
Nasreen Sayed
214-645-6965
nasreen.sayed@utsouthwestern.edu

Principal Investigator
Edson Brown

Summary

a 52-week, randomized, double-blind, placebo-controlled, crossover trial of memantine in 50 outpatients receiving chronic prednisone therapy is proposed. Differences in declarative memory as assessed by the HVLT will be the primary clinical outcome. additional outcomes will be analyses of other cognitive domains sensitive to hippocampal functioning and working memory, spectroscopy, and relationships between corticosteroid dose and duration and outcome measures. Hippocampal and amygdalar volume will also be explored.

Home visits will be available for the patient if for some reason the patient cannot keep their appointment at the office. Home visits will involve two research assistants going to the patient's home to perform the necessary weekly assessments. Psychiatric follow-up/evaluation will be performed via phone or webcam. in the case where assessments/tests must be performed at uTSW campus (e.g. MRi), the patient will have to transport themselves to uTSW campus.

Participant Eligibility

*Diagnosis of any chronic medical condition requiring treatment with oral corticosteroids confirmed by chart review and/or patient assessment by Dr. Khan (co-I).

*Receiving prednisone therapy of at least 5 mg of prednisone/day for >= 6 months with anticipated treatment for >= 12 additional months. This is a dose and duration associated with systemic side effects (e.g., Cushingoid features).

*Age 18-60 years. Older patients are excluded to minimize the possibility of enrolling participants with early dementias and to minimize sample heterogeneity.

*Baseline CVLT-2 total T score <= 54. This criterion will exclude potential participants with above average declarative memory at baseline (a group potentially less likely to benefit from the intervention).