Memory and Attention Problems in Lupus: New Treatment Trial With Modafinil
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot and Feasibility Study of Modafinil Treatment to Improve Cognitive Efficiency in SLE Patients|
- Improvement in cognitive efficiency at 6 weeks
- Change in performance of cognitive activities at six weeks
- Change in fatigue at six weeks
- Change in sleep at six weeks
- Adverse events, including an increase in SLE activity, at six weeks
|Study Start Date:||February 2006|
|Estimated Study Completion Date:||February 2007|
This is a 6-week pilot and feasibility single-arm, open-label trial of modafinil 200mg orally every morning to improve cognitive efficiency in systemic lupus patients with cognitive difficulties in daily life.
Cognitive dysfunction is a well-recognized manifestation of systemic lupus erythematosus (SLE) whose reported prevalence ranges from 12-87%. SLE-associated cognitive dysfunction often occurs in the absence of frank neuropsychiatric disease (e.g., stroke, depression, psychosis, cerebral vasculitis), medications known to have central nervous system effects, or increased disease activity or flare. Studies of SLE antibodies (most notably the antiphospholipid antibodies) have provided conflicting results with respect to their association with SLE-associated cognitive dysfunction. Thus, despite numerous investigations, the etiology of SLE-associated cognitive dysfunction remains unclear. There is no known means for preventing cognitive dysfunction in SLE. Similarly there are no established or proven treatments for cognitive dysfunction in SLE.
Regardless of its cause, course, or long-term consequences, cognitive dysfunction in SLE is a major cause of distress, compromised performance of everyday activities, and decreased quality of life. Thus, treatment of decreased cognitive performance in SLE when it occurs, no matter how mild, and regardless of its potential for permanence or progression, is of paramount importance. It is imperative to provide SLE patients with cognitive performance difficulties with the means to functionally cope with their impairments so that they can maintain, if not regain their independence.
Modafinil is a safe, orally administered wakefulness-promoting agent approved for use in adults suffering from narcolepsy, idiopathic hypersomnia, obstructive sleep apnea, and shift work sleep syndrome. Since its FDA approval, it has been used for many additional varied conditions including depression, fatigue, fibromyalgia, myotonic dystrophy, organic brain syndrome, sleep deprivation, Parkinson's, and drug-induced somnolence. It has also been used in helicopter and airplane pilots to enhance their attentiveness during long flights. Some of our SLE patients have been prescribed modafinil for narcolepsy or associated fatigue.
Modafinil has broad efficacy in health and illness. It enhances cognitive function in normal young adult males, as tested by digit span, visual pattern recognition memory, spatial planning and stop-signal reaction time. While the majority of patients prescribed modafinil received the drug for non-cognitive indications (e.g., fatigue, sleepiness), several have reported improved cognitive function, especially with respect to tasks that require attention and concentration.
We hypothesize that Modafinil, an FDA-approved, non-specific wakefulness-promoting agent with minimal side effects, is safe and effective when used to improve cognitive efficiency in SLE patients who identify cognitive dysfunction in themselves.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297284
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Melanie J. Harrison, MD, MS||Hospital for Special Surgery, New York|