PREVALENCE of HIV-ASSOCIATED NEUROCOGNITIVE DISORDERS (HAND) in a SCHOOL of MEDICINE HIV/AIDS OUTPATIENT CLINIC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- IADL (Instrumental Activities of Daily Living Scale)
研究概览
简要总结
- To determine, in the Quillen College of Medicine HIV+ outpatient clinic, the prevalence of
- NC (normal cognition )
- ANI (asymptomatic neurocognitive impairment )
- MCD (mild cognitive disorder )
- HAD (HIV-associated dementia )
- To determine whether the following variables affect the three categories of HAND
- Time since first diagnosis of HIV infection
- Anti-viral medications used
- Age
- Gender
详细描述
As life expectancy increases, dementia becomes more common, and the need for its correct diagnosis and treatment becomes more urgent. Alzheimer's disease (AD) is the leading cause of dementia, but its diagnosis is by exclusion of all other causes. Successful treatment of HIV/AIDS has resulted in more patients living long enough to develop HIV-Associated Neurocognitive Disorders (HAND), including dementia.
The National Institute of Mental Health, and the National Institute of Neurological Diseases and Stroke, updated standards for diagnosing HAND. The new criteria created an additional category, HIV-associated asymptomatic neurocognitive impairment (ANI), and modified the name and criteria for what was called MCMD (minor cognitive/motor disorder) to mild cognitive disorder (MCD). HIV-associated dementia (HAD) remained unchanged. Their definition of HAND includes: Cognitive impairment must be attributable to HIV and no other etiology (Dementia, Delirium, Depression, CNS neoplasm, CNS infection other than HIV/AIDS. Cerebrovascular disease, Substance abuse). Their criteria state that cognitive impairment should be validated by neuropsychological testing.
The three categories of HAND are:
- HIV-associated asymptomatic neurocognitive impairment (ANI)
Impairment involves at least two cognitive domains, and results in neuropsychological testing performance at least 1 Standard Deviation (SD) below the appropriate mean age/education norm for:
- Information processing speed
- Sensory/motor skills
- Short-term and long-term memory
- Ability to learn new skills and solve problems
- Attention, concentration, and distractibility
- Logical and abstract reasoning functions
- Ability to understand and express language
- Visual-spatial organization Visual-motor coordination
- Planning, synthesizing and organizing abilities
- Mild Cognitive Disorder (MCD) Same as ANI but patient or caregivers report that cognitive deficit interferes with mental acuity, work efficiency, home making or social activity
- HIV-associated dementia (HAD)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants will have been diagnosed as HIV+.
- •Health controls with be age (+/- 5 years) and gender matched to the HIV+ participants.
排除标准
- •Alzheimer's DIsease
- •Vascular Dementia
- •Severe Depression
- •CNS Neoplasm
- •CNS Infection Other Than HIV/AIDS
- •Cerebrovascular Disease
- •Alcohol Or Drug Intoxication Or Dependence
- •Parkinson's
- •Thyroid Disease
- •Pernicious Anemia
- •Subdural Hematoma
- •Occult Hydrocephalus
- •Huntington's
- •Creutzfeldt-Jakob
- •Electroconvulsive Therapy
- •Seizure Disorder
- •Medical/Psychiatric Disease
- •Medication Influencing Cognition
结局指标
主要结局
IADL (Instrumental Activities of Daily Living Scale)
时间窗: at enrollment
HAND criteria include normal activities of daily living for NC and ANI, and impairment of these activities in MCD and HAD. The Instrumental Activities of Daily Living Scale will determine whether the cognitive impairment is interfering with work, home life, social activity or other activities of daily living. The maximum IADL score of 8, means no impairment in any of the following 8 activities; telephoning, shopping, preparing food, housekeeping, laundry, travel, medications and finances. A score of 7 or less will indicate impairment.
IntegNeuro
时间窗: at enrollment
IntegNeuro is a touch-screen computerized neuropsychological assessment tool which tests the following cognitive domains: * Motor Tapping * Choice Reaction Time * Time Estimation * Word Generation * Digit Span * Memory recall \& Recognition * Spot the Word * Span of Visual Memory * Continuous Performance Test * Verbal Interference * Switching of Attention * Maze * Go/No-Go * Emotion Processing
Medical Outcomes Study HIV (MOS-HIV) Health Survey
时间窗: at enrollment
The Medical Outcomes Study HIV (MOS-HIV) Health Survey is a widely used instrument to assess quality of life in HIV-1-infected individuals. Its cognitive functional status subscale measures functional status owing to neuropsychological (NP) impairment.
次要结局
- MMSE (Mini Mental State Exam)(at enrollment)
- COGNISION P300 ODD- BALL DEVICE(at enrollment)
研究者
Dr. Norman Moore
Director of Research, Department of Psychiatry
East Tennessee State University