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Comparison of the effects of modafinil as an adjunct therapy to CPAP in alert and cognitive function in patients with Alzheimer's Disease (AD) and obstructive sleep apnea-hypopnea syndrome

Grant number: 07/00432-7
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): November 01, 2007
Effective date (End): April 30, 2009
Field of knowledge:Health Sciences - Medicine - Medical Clinics
Principal Investigator:Lia Rita Azeredo Bittencourt
Grantee:Paulo Eduardo Braga Pierozzi
Home Institution: Departamento de Psicobiologia. Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

The reason for this study is based on the knowledge that Excessive Daytime Sleepiness (EDS) and cognitive dysfunction will appear in patients with Alzheimer's Disease (AD) and Obstructive Sleep Apnea (OSA). The use of a drug like modafinil should have an important role on decrease of EDS and increase of cognitive function of these patients. This drug has showed minimal side effects, low abuse potential and there is no clinical evidence for the development of dependence or tolerance. The benefits of modafinil treatment in patients with Alzheimer Disease (AD) and Obstructive Sleep Apnea (OSA) have not been evaluated. The purpose of this study is to evaluate the effect of modafinil in daytime alertness and cognitive function in patients with Alzheimer Disease and Obstructive Sleep Apnea (OSA). This is a randomized double-blind placebo controlled study. A group of 50 patients with Alzheimer's disease (mild to moderate disease) and Obstructive Sleep Apnea (OSA) (apnea hypopnea index > 10 events/h) will participate on the study. It will include patients with: Alzheimer's disease; CDR-1 and CDR-2 (Clinical Dementia Rating); presence of obstructive sleep apnea (AHI > 10 events/h); age from 60 to 80 years old, male or female, patients without previous treatment for OSA. It will exclude patients with: unstable medical or psychiatric disease; under psychiatric treatment and in use of psychiatric medication; alcohol abuse; in use of stimulant medications; history of agitation or confusional behavior; using CPAP, BIPAP or oxygen; using hypnotic medication. The protocol will consist of: initial evaluation after confirmation of diagnosis, after 30 days of treatment (modafinil 200mg/placebo) and after 60 days of CPAP use (CPAP + modafinil or CPAP + placebo). The following evaluations will be realized: clinical interview, Epworth sleepiness scale; fatigue severity scale, cognitive testing (ADS-cog); Mini-Mental State Examination (MMSE); depression scale (Hamilton); quality of life scale (SF-36); actigraphy for one week, nocturnal polissonographyc study; event-related potentials (ERPs), performance vigilance test (PVT); maintenance of wakefulness test (MWT). (AU)