Prevalence of HIV-associated Neurocognitive Disorders (HAND) in a School of Medicine HIV/AIDS Outpatient Clinic

NCT02187796 | Completed

• 1 other identifier: 0214.24s
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND)

Keywords

HIV; Dementia; HAND; COGNISION System; ERP; event-related potentials

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  at enrollment

Secondary Outcomes (2)

• MMSE (Mini Mental State Exam)

  at enrollment

• COGNISION P300 ODD- BALL DEVICE

  at enrollment

Study Arms (5)

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

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV+ individuals and Healthy controls (HIV-, age and gender matched)

You may qualify if:

• All participants will have been diagnosed as HIV+.
• Health controls with be age (+/- 5 years) and gender matched to the HIV+ participants.

You may not qualify if:

• 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

Sponsors & Collaborators

• East Tennessee State University: lead
• Neuronetrix, Inc.: collaborator

Study Sites (1)

Quillen College of Medicine at East Tennessee State University

Johnson City, Tennessee, 37614, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Norman C Moore, MD

  Psychiatry and Behavioral Sciences, Quillen College of Medicine, East Tennessee State University

  PRINCIPAL INVESTIGATOR

• Jonathan P Moorman, MD,Ph.D,FACP

  Infectious Diseases, Internal Medicine, Quillen College of Medicine, East Tennessee State University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Department of Psychiatry

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 11, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

US (1)