- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02187796
Prevalence of HIV-associated Neurocognitive Disorders (HAND) in a School of Medicine HIV/AIDS Outpatient Clinic (HAND)
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
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tennessee
-
Johnson City, Tennessee, United States, 37614
- Quillen College of Medicine at East Tennessee State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All participants will have been diagnosed as HIV+.
- Health controls with be age (+/- 5 years) and gender matched to the HIV+ participants.
Exclusion Criteria:
- Alzheimer's DIsease
- Vascular Dementia
- Delirium
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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:
|
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:
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IntegNeuro
Time Frame: at enrollment
|
IntegNeuro is a touch-screen computerized neuropsychological assessment tool which tests the following cognitive domains:
|
at enrollment
|
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.
|
at enrollment
|
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.
|
at enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MMSE (Mini Mental State Exam)
Time Frame: at enrollment
|
The mini-mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment.
|
at enrollment
|
COGNISION P300 ODD- BALL DEVICE
Time Frame: at enrollment
|
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).
|
at enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Norman C Moore, MD, Psychiatry and Behavioral Sciences, Quillen College of Medicine, East Tennessee State University
- Study Chair: Jonathan P Moorman, MD,Ph.D,FACP, Infectious Diseases, Internal Medicine, Quillen College of Medicine, East Tennessee State University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0214.24s
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND)
-
St Vincent's Hospital, SydneyUnknownHIV | HIV-associated Neurocognitive Disorder (HAND)Australia
-
University of CalgaryCanadian Institutes of Health Research (CIHR); University of Alberta; Epidemiology...TerminatedHIV Associated Neurocognitive Disorder (HAND)Canada
-
UMC UtrechtGilead SciencesCompletedHIV Associated Neurocognitive Disorder | Neurocognitive DeclineNetherlands
-
GCS IHFB Cognacq-JayHospital Ambroise Paré ParisCompletedHIV-1-infection | HIV Associated Neurocognitive DisorderFrance
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)CompletedHIV Associated Neurocognitive DisorderUnited States
-
Massachusetts General HospitalMerck Sharp & Dohme LLCCompletedHIV | Neurotoxicity | HIV-associated Neurocognitive DisorderUnited States
-
Posit Science CorporationCompletedHIV-associated Neurocognitive DysfunctionUnited States
-
Bruce BrewViiV HealthcareCompletedHuman Immunodeficiency Virus (HIV) | HIV Associated Neurocognitive Disorders (HAND)Australia
-
St Vincent's Hospital, SydneyMerck Sharp & Dohme LLCTerminatedHuman Immunodeficiency Virus (HIV) | HIV Associated Neurocognitive Disorders (HAND)Australia
-
Fundació Institut de Recerca de l'Hospital de la...Hospital Clinic of Barcelona; University of BarcelonaCompletedHIV-associated Hypertriglyceridemia | HIV-associated Hypercholesterolemia | HIV-associated Inflammatory StateSpain