HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND)HANDNCT02187796
Prevalence of HIV-associated Neurocognitive Disorders (HAND) in a School of Medicine HIV/AIDS Outpatient Clinic
An observational study of HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND), run by East Tennessee State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV+ individuals and Healthy controls (HIV-, age and gender matched)
Who may be able to join
- All participants will have been diagnosed as HIV+.
- Health controls with be age (+/- 5 years) and gender matched to the HIV+ participants.
Who cannot join
- Alzheimer's DIsease
- Vascular Dementia
- Delirium
- Severe Depression
- CNS Neoplasm
- CNS Infection Other Than HIV/AIDS
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Quillen College of Medicine at East Tennessee State University
Johnson City, Tennessee, 37614
About this study
Official title: PREVALENCE of HIV-ASSOCIATED NEUROCOGNITIVE DISORDERS (HAND) in a SCHOOL of MEDICINE HIV/AIDS OUTPATIENT CLINIC
- 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
Read the detailed description
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) 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.
- 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.
- Keywords
- HIV, Dementia, HAND, COGNISION System, ERP, event-related potentials
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Cognition | HIV+ individuals with no detectable neurocognitive impairment | |
| ANI (asymptomatic neurocognitive impairment) | 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 | |
| MCD (Mild Cognitive Disorder) | 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 | |
| HAD (HIV-associated dementia) | 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. | |
| Healthy Controls (HIV-) | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
IntegNeuro
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
Measured: at enrollment
IADL (Instrumental Activities of Daily Living Scale)
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.
Measured: at enrollment
Medical Outcomes Study HIV (MOS-HIV) Health Survey
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.
Measured: at enrollment
Secondary outcomes (2)
MMSE (Mini Mental State Exam)
The mini-mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment.
Measured: at enrollment
COGNISION P300 ODD- BALL DEVICE
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).
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Tennessee State University
- Sponsor type
- University, hospital or other
- Collaborators
- Neuronetrix, Inc.
- Responsible party
- Principal investigator, Dr. Norman Moore, East Tennessee State University
- Investigators
- Norman C Moore, MD, Principal investigator, Psychiatry and Behavioral Sciences, Quillen College of Medicine, East Tennessee State UniversityJonathan P Moorman, MD,Ph.D,FACP, Study chair, Infectious Diseases, Internal Medicine, Quillen College of Medicine, East Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187796
- Sponsor's protocol ID
- 0214.24s
- Acronym
- HAND
- Status last verified
- Aug 2015
- First submitted
- 9 Jul 2014
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVALENCE of HIV-ASSOCIATED NEUROCOGNITIVE DISORDERS (HAND) in a SCHOOL of MEDICINE HIV/AIDS OUTPATIENT CLINIC
- ClinicalTrials.gov ID
- NCT02187796
- Acronym / sponsor ID
- HAND / 0214.24s
- Keywords
- HIV, Dementia, HAND, COGNISION System, ERP, event-related potentials
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- East Tennessee State UniversityUniversity, hospital or other
- Collaborators
- Neuronetrix, Inc.
- Study start
- May 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Detailed description
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) 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal Cognition | – | –HIV+ individuals with no detectable neurocognitive impairment |
| ANI (asymptomatic neurocognitive impairment) | – | –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 |
| MCD (Mild Cognitive Disorder) | – | –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 |
| HAD (HIV-associated dementia) | – | –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. |
| Healthy Controls (HIV-) | – | –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 |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV+ individuals and Healthy controls (HIV-, age and gender matched)
Key inclusion criteria (2 listed)
- All participants will have been diagnosed as HIV+.
- Health controls with be age (+/- 5 years) and gender matched to the HIV+ participants.
Key exclusion criteria (19 listed)
- Alzheimer's DIsease
- Vascular Dementia
- Delirium
- Severe Depression
- CNS Neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IntegNeuro
Time frame: 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
IADL (Instrumental Activities of Daily Living Scale)
Time frame: 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.
Medical Outcomes Study HIV (MOS-HIV) Health Survey
Time frame: 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.
2 secondary outcomes
MMSE (Mini Mental State Exam)
Time frame: at enrollment
COGNISION P300 ODD- BALL DEVICE
Time frame: at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
Related trials for HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND)
RecruitingObservational study
Thinking and Memory Problems in People With HIV
HIV Positive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman C Moore, MD principal investigator
Psychiatry and Behavioral Sciences, Quillen College of Medicine, East Tennessee State University
Jonathan P Moorman, MD,Ph.D,FACP study chair
Infectious Diseases, Internal Medicine, Quillen College of Medicine, East Tennessee State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND), run by East Tennessee State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IntegNeuro (time frame: at enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.