Attenuation of Corticosteroid Induced Hippocampal Changes
Condition: Organic Memory Impairment
Intervention: Memantine 10 mg capsule; Memantine-matched Placebo capsule
Intervention description: Memantine oral capsule was initiated at 5 mg/day at Randomization (Week 0), then titrated to 5 mg twice a day at Week 2, then increased to 10 mg in the morning and 5 mg in the evening at Week 3, and then to 10 mg twice a day (intervention dose) at Weeks 4-24. For the participants in the "Placebo, then Memantine" arm, the same titration schedule was maintained after the 4-week washout period (Week 28-52).; Memantine-matched oral Placebo capsule was initiated at Randomization (Week 0) and maintained Weeks 0-24 in a manner consistent with the active drug titration schedule. The number of placebo capsules matched the number of active drug capsules at each titration checkpoint. For the participants in the "Memantine, then Placebo" arm, the same titration schedule was maintained after the 4-week washout period (Week 28-52).
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: memantine; cognition; corticosteroid; prednisone; memory; hippocampus

Summary:

      The purpose of the study is to determine if an investigational drug called memantine,used
      here as add-on therapy, is associated with improvements in memory, mood and asthma symptoms.
      We will also examine changes in the brain by taking images or pictures using an MRI/MRS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 at least 6 months
             with anticipated treatment for ≥ 12 additional months.

          -  Age 18-65 years.

          -  Baseline CVLT-II total T score ≤ 54.

        Exclusion Criteria:

          -  Illnesses associated with CNS involvement (e.g., seizures, brain tumors, head injury
             with loss of consciousness) or cognitive impairment (e.g., substance dependence within
             the past 2 years, bipolar disorder) Potential participants with mood symptoms
             secondary to corticosteroids (based on SCID) will not be excluded because this could
             selectively exclude subjects who are sensitive to the CNS effects of corticosteroids.

          -  Vulnerable populations (e.g. severe cognitive impairment, pregnant or nursing women,
             prisoners).

          -  Severe or life-threatening medical illness that would make completion of study
             unlikely

          -  Contraindications to memantine therapy (e.g. severe side effects in the past)

          -  Danger to self or others as defined by > 1 lifetime suicide attempt or assault, any
             suicide attempt or assault within the past year, and active suicidal or homicidal
             ideation with plan and intent.

          -  Metal implants, claustrophobia, or other contraindications to MRI