HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND) Clinical Trial
Official title:
PREVALENCE of HIV-ASSOCIATED NEUROCOGNITIVE DISORDERS (HAND) in a SCHOOL of MEDICINE HIV/AIDS OUTPATIENT CLINIC
1. 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 )
2. 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
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:
1. 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
2. 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
3. HIV-associated dementia (HAD)
Impairment involves at least two cognitive domains and results in neuropsychological
testing at least 2 SD below the appropriate mean age/education norm for:
- Information processing speed
- 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 Cognitive impairment significantly
interferes with work, home life, social activities or ADL's.
4. Non-HIV healthy Controls
Our P300 COGNISION apparatus, provided by Neuronetrix, has been used only in subjects over
the age of 60, whereas our participants in the HAND study will all be younger than 60. So,
we cannot use COGNISION normative data base for comparison. We will add 10 HIV- healthy
controls to our planned 40 HIV+ subjects. These HIV- participants will be age- and
gender-matched to the HIV- Asymptomatic Neurocognitive Impairment (ANI) patients, and will
undergo all the same assessments
Our IRB-approved study of HAND is limited to neuropsychological assessment. The study could
be improved by adding a biological marker assessment, which could help validate the HAND
categories. Such a marker is the P300 event-related potential (ERP), known to be related to
cognitive processes, such as attention and working memory and abnormal in most neurologic
and mental disorders. It could also possibly detect vulnerability to later cognitive
impairment in those determined to be of normal cognition by neuropsychological testing. For
example, Olichney et al (2011) concluded that ERP studies of individuals at risk for AD may
reveal neurophysiological changes prior to clinical deficits, which could advance the early
detection and diagnosis of "pre-symptomatic AD". Another example of the association of the
P300 and cognition was the study of Onofri et al (2003). In this study donepezil resulted in
improved cognition, as measured by a significant increase in MMSE scores. This was
accompanied by a reduction of P3 latency. Logistic analysis showed that P3 latency predicted
the beneficial effect of donepezil.
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Observational Model: Case Control, Time Perspective: Cross-Sectional
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02989285 -
Identification and Quantification of HIV CNS Latency Biomarkers
|