<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02187796</url>
  </required_header>
  <id_info>
    <org_study_id>0214.24s</org_study_id>
    <nct_id>NCT02187796</nct_id>
  </id_info>
  <brief_title>Prevalence of HIV-associated Neurocognitive Disorders (HAND) in a School of Medicine HIV/AIDS Outpatient Clinic</brief_title>
  <acronym>HAND</acronym>
  <official_title>PREVALENCE of HIV-ASSOCIATED NEUROCOGNITIVE DISORDERS (HAND) in a SCHOOL of MEDICINE HIV/AIDS OUTPATIENT CLINIC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>East Tennessee State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Neuronetrix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>East Tennessee State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To determine, in the Quillen College of Medicine HIV+ outpatient clinic, the prevalence&#xD;
           of&#xD;
&#xD;
             -  NC (normal cognition )&#xD;
&#xD;
             -  ANI (asymptomatic neurocognitive impairment )&#xD;
&#xD;
             -  MCD (mild cognitive disorder )&#xD;
&#xD;
             -  HAD (HIV-associated dementia )&#xD;
&#xD;
        2. To determine whether the following variables affect the three categories of HAND&#xD;
&#xD;
             -  Time since first diagnosis of HIV infection&#xD;
&#xD;
             -  Anti-viral medications used&#xD;
&#xD;
             -  Age&#xD;
&#xD;
             -  Gender&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As life expectancy increases, dementia becomes more common, and the need for its correct&#xD;
      diagnosis and treatment becomes more urgent. Alzheimer's disease (AD) is the leading cause of&#xD;
      dementia, but its diagnosis is by exclusion of all other causes. Successful treatment of&#xD;
      HIV/AIDS has resulted in more patients living long enough to develop HIV-Associated&#xD;
      Neurocognitive Disorders (HAND), including dementia.&#xD;
&#xD;
      The National Institute of Mental Health, and the National Institute of Neurological Diseases&#xD;
      and Stroke, updated standards for diagnosing HAND. The new criteria created an additional&#xD;
      category, HIV-associated asymptomatic neurocognitive impairment (ANI), and modified the name&#xD;
      and criteria for what was called MCMD (minor cognitive/motor disorder) to mild cognitive&#xD;
      disorder (MCD). HIV-associated dementia (HAD) remained unchanged. Their definition of HAND&#xD;
      includes: Cognitive impairment must be attributable to HIV and no other etiology (Dementia,&#xD;
      Delirium, Depression, CNS neoplasm, CNS infection other than HIV/AIDS. Cerebrovascular&#xD;
      disease, Substance abuse). Their criteria state that cognitive impairment should be validated&#xD;
      by neuropsychological testing.&#xD;
&#xD;
      The three categories of HAND are:&#xD;
&#xD;
        1. HIV-associated asymptomatic neurocognitive impairment (ANI)&#xD;
&#xD;
           Impairment involves at least two cognitive domains, and results in neuropsychological&#xD;
           testing performance at least 1 Standard Deviation (SD) below the appropriate mean&#xD;
           age/education norm for:&#xD;
&#xD;
             -  Information processing speed&#xD;
&#xD;
             -  Sensory/motor skills&#xD;
&#xD;
             -  Short-term and long-term memory&#xD;
&#xD;
             -  Ability to learn new skills and solve problems&#xD;
&#xD;
             -  Attention, concentration, and distractibility&#xD;
&#xD;
             -  Logical and abstract reasoning functions&#xD;
&#xD;
             -  Ability to understand and express language&#xD;
&#xD;
             -  Visual-spatial organization Visual-motor coordination&#xD;
&#xD;
             -  Planning, synthesizing and organizing abilities&#xD;
&#xD;
        2. Mild Cognitive Disorder (MCD) Same as ANI but patient or caregivers report that&#xD;
           cognitive deficit interferes with mental acuity, work efficiency, home making or social&#xD;
           activity&#xD;
&#xD;
        3. HIV-associated dementia (HAD)&#xD;
&#xD;
           Impairment involves at least two cognitive domains and results in neuropsychological&#xD;
           testing at least 2 SD below the appropriate mean age/education norm for:&#xD;
&#xD;
             -  Information processing speed&#xD;
&#xD;
             -  Short-term and long-term memory&#xD;
&#xD;
             -  Ability to learn new skills and solve problems&#xD;
&#xD;
             -  Attention, concentration, and distractibility&#xD;
&#xD;
             -  Logical and abstract reasoning functions&#xD;
&#xD;
             -  Ability to understand and express language&#xD;
&#xD;
             -  Visual-spatial organization Visual-motor coordination&#xD;
&#xD;
             -  Planning, synthesizing and organizing abilities Cognitive impairment significantly&#xD;
                interferes with work, home life, social activities or ADL's.&#xD;
&#xD;
        4. Non-HIV healthy Controls&#xD;
&#xD;
      Our P300 COGNISION apparatus, provided by Neuronetrix, has been used only in subjects over&#xD;
      the age of 60, whereas our participants in the HAND study will all be younger than 60. So, we&#xD;
      cannot use COGNISION normative data base for comparison. We will add 10 HIV- healthy controls&#xD;
      to our planned 40 HIV+ subjects. These HIV- participants will be age- and gender-matched to&#xD;
      the HIV- Asymptomatic Neurocognitive Impairment (ANI) patients, and will undergo all the same&#xD;
      assessments&#xD;
&#xD;
      Our IRB-approved study of HAND is limited to neuropsychological assessment. The study could&#xD;
      be improved by adding a biological marker assessment, which could help validate the HAND&#xD;
      categories. Such a marker is the P300 event-related potential (ERP), known to be related to&#xD;
      cognitive processes, such as attention and working memory and abnormal in most neurologic and&#xD;
      mental disorders. It could also possibly detect vulnerability to later cognitive impairment&#xD;
      in those determined to be of normal cognition by neuropsychological testing. For example,&#xD;
      Olichney et al (2011) concluded that ERP studies of individuals at risk for AD may reveal&#xD;
      neurophysiological changes prior to clinical deficits, which could advance the early&#xD;
      detection and diagnosis of &quot;pre-symptomatic AD&quot;. Another example of the association of the&#xD;
      P300 and cognition was the study of Onofri et al (2003). In this study donepezil resulted in&#xD;
      improved cognition, as measured by a significant increase in MMSE scores. This was&#xD;
      accompanied by a reduction of P3 latency. Logistic analysis showed that P3 latency predicted&#xD;
      the beneficial effect of donepezil.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>IntegNeuro</measure>
    <time_frame>at enrollment</time_frame>
    <description>IntegNeuro is a touch-screen computerized neuropsychological assessment tool which tests the following cognitive domains:&#xD;
Motor Tapping&#xD;
Choice Reaction Time&#xD;
Time Estimation&#xD;
Word Generation&#xD;
Digit Span&#xD;
Memory recall &amp; Recognition&#xD;
Spot the Word&#xD;
Span of Visual Memory&#xD;
Continuous Performance Test&#xD;
Verbal Interference&#xD;
Switching of Attention&#xD;
Maze&#xD;
Go/No-Go&#xD;
Emotion Processing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IADL (Instrumental Activities of Daily Living Scale)</measure>
    <time_frame>at enrollment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical Outcomes Study HIV (MOS-HIV) Health Survey</measure>
    <time_frame>at enrollment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MMSE (Mini Mental State Exam)</measure>
    <time_frame>at enrollment</time_frame>
    <description>The mini-mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COGNISION P300 ODD- BALL DEVICE</measure>
    <time_frame>at enrollment</time_frame>
    <description>The P300 is evoked by an &quot;oddball' sound of high pitch and irregular timing, compared with sound of lower pitch and regular timing. The subject is asked to count oddball and ignore regular sounds. The P300 is a positive waveform, usually at 300 milliseconds after the oddball sensory input. The COGNISION System is an electroencephalographic (EEG) device that records microvolt level voltage potentials from the subject's scalp. It collects electrophysiological responses to external auditory stimuli, such as in the P300 paradigm. It is composed of (1) a Headset Assembly to be placed on the subject's head at the time of the test, (2) a handheld Headset Control Unit (HCU) to operate the device, (3) computer software to order and monitor the test and analyze the test results, (4) standard stereo earphones (for auditory ERPs).</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND)</condition>
  <arm_group>
    <arm_group_label>Normal Cognition</arm_group_label>
    <description>HIV+ individuals with no detectable neurocognitive impairment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ANI (asymptomatic neurocognitive impairment)</arm_group_label>
    <description>HIV+ individuals where 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:&#xD;
Information processing speed&#xD;
Sensory/motor skills&#xD;
Short-term and long-term memory&#xD;
Ability to learn new skills and solve problems&#xD;
Attention, concentration, and distractibility&#xD;
Logical and abstract reasoning functions&#xD;
Ability to understand and express language&#xD;
Visual-spatial organization Visual-motor coordination&#xD;
Planning, synthesizing and organizing abilities</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MCD (Mild Cognitive Disorder)</arm_group_label>
    <description>HIV+ individuals with cognitive impairment same as ANI but patient or caregivers report that cognitive deficit interferes with mental acuity, work efficiency, home making or social activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HAD (HIV-associated dementia)</arm_group_label>
    <description>HIV+ individuals where impairment involves at least two cognitive domains and results in neuropsychological testing at least 2 SD below the appropriate mean age/education norm for:&#xD;
Information processing speed&#xD;
Short-term and long-term memory&#xD;
Ability to learn new skills and solve problems&#xD;
Attention, concentration, and distractibility&#xD;
Logical and abstract reasoning functions&#xD;
Ability to understand and express language&#xD;
Visual-spatial organization Visual-motor coordination&#xD;
Planning, synthesizing and organizing abilities Cognitive impairment significantly interferes with work, home life, social activities or ADL's.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls (HIV-)</arm_group_label>
    <description>Our P300 COGNISION apparatus 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</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        HIV+ individuals and Healthy controls (HIV-, age and gender matched)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants will have been diagnosed as HIV+.&#xD;
&#xD;
          -  Health controls with be age (+/- 5 years) and gender matched to the HIV+ participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alzheimer's DIsease&#xD;
&#xD;
          -  Vascular Dementia&#xD;
&#xD;
          -  Delirium&#xD;
&#xD;
          -  Severe Depression&#xD;
&#xD;
          -  CNS Neoplasm&#xD;
&#xD;
          -  CNS Infection Other Than HIV/AIDS&#xD;
&#xD;
          -  Cerebrovascular Disease&#xD;
&#xD;
          -  Alcohol Or Drug Intoxication Or Dependence&#xD;
&#xD;
          -  Parkinson's&#xD;
&#xD;
          -  Thyroid Disease&#xD;
&#xD;
          -  Pernicious Anemia&#xD;
&#xD;
          -  Subdural Hematoma&#xD;
&#xD;
          -  Occult Hydrocephalus&#xD;
&#xD;
          -  Huntington's&#xD;
&#xD;
          -  Creutzfeldt-Jakob&#xD;
&#xD;
          -  Electroconvulsive Therapy&#xD;
&#xD;
          -  Seizure Disorder&#xD;
&#xD;
          -  Medical/Psychiatric Disease&#xD;
&#xD;
          -  Medication Influencing Cognition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Norman C Moore, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Psychiatry and Behavioral Sciences, Quillen College of Medicine, East Tennessee State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jonathan P Moorman, MD,Ph.D,FACP</last_name>
    <role>Study Chair</role>
    <affiliation>Infectious Diseases, Internal Medicine, Quillen College of Medicine, East Tennessee State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quillen College of Medicine at East Tennessee State University</name>
      <address>
        <city>Johnson City</city>
        <state>Tennessee</state>
        <zip>37614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>August 3, 2015</last_update_submitted>
  <last_update_submitted_qc>August 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>East Tennessee State University</investigator_affiliation>
    <investigator_full_name>Dr. Norman Moore</investigator_full_name>
    <investigator_title>Director of Research, Department of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Dementia</keyword>
  <keyword>HAND</keyword>
  <keyword>COGNISION System</keyword>
  <keyword>ERP</keyword>
  <keyword>event-related potentials</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurocognitive Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02187796
org study id: 0214.24s
nct id: NCT02187796
lead sponsor: 
collaborator: 
has dmc: No
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: IntegNeuro
time frame: at enrollment
description: 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
measure: IADL (Instrumental Activities of Daily Living Scale)
time frame: at enrollment
description: 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.
measure: Medical Outcomes Study HIV (MOS-HIV) Health Survey
time frame: at enrollment
description: 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.
measure: MMSE (Mini Mental State Exam)
time frame: at enrollment
description: The mini-mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment.
measure: COGNISION P300 ODD- BALL DEVICE
time frame: at enrollment
description: The P300 is evoked by an "oddball' sound of high pitch and irregular timing, compared with sound of lower pitch and regular timing. The subject is asked to count oddball and ignore regular sounds. The P300 is a positive waveform, usually at 300 milliseconds after the oddball sensory input. The COGNISION System is an electroencephalographic (EEG) device that records microvolt level voltage potentials from the subject's scalp. It collects electrophysiological responses to external auditory stimuli, such as in the P300 paradigm. It is composed of (1) a Headset Assembly to be placed on the subject's head at the time of the test, (2) a handheld Headset Control Unit (HCU) to operate the device, (3) computer software to order and monitor the test and analyze the test results, (4) standard stereo earphones (for auditory ERPs).
arm group label: Normal Cognition
description: HIV+ individuals with no detectable neurocognitive impairment
arm group label: ANI (asymptomatic neurocognitive impairment)
description: HIV+ individuals where 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
arm group label: MCD (Mild Cognitive Disorder)
description: HIV+ individuals with cognitive impairment same as ANI but patient or caregivers report that cognitive deficit interferes with mental acuity, work efficiency, home making or social activity
arm group label: HAD (HIV-associated dementia)
description: HIV+ individuals where 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.
arm group label: Healthy Controls (HIV-)
description: Our P300 COGNISION apparatus 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
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Norman C Moore, MD
role: Principal Investigator
affiliation: Psychiatry and Behavioral Sciences, Quillen College of Medicine, East Tennessee State University
last name: Jonathan P Moorman, MD,Ph.D,FACP
role: Study Chair
affiliation: Infectious Diseases, Internal Medicine, Quillen College of Medicine, East Tennessee State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: East Tennessee State University
investigator full name: Dr. Norman Moore
investigator title: Director of Research, Department of Psychiatry
mesh term: Neurocognitive Disorders