Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients (NEURACog)

The objective of this prospective study is to evaluate the prevalence of neurocognitive impairments in HIV infected patients comparing patients with and without HAART. Recent studies have demonstrated a specific HIV infected patients neurocognitive disorders profile. These cognitive disorders concern primarily information processing speed, memory recall, attentional abilities, work related memory, executive functions, and psychometrical speed. This cognitive profile is similar to another highly documented one, described for another central nervous system disease (CNS): multiple sclerosis. In both CNS diseases, the earliest and most severe disorder is the one related to the information processing speed. For the multiple sclerosis patients, a short cognitive test (SDMT) is actually used not only to identify cognitive disorders presence, but also in order to predict a long term disability worsening. A digital version of this test (CSCT), has recently been developed in order to make this early evaluation easier. We hypothesize that CSCT alteration would also predict HAND, in HIV infected patients. A complete neuropsychological assessment is highly time and personal consuming. This short (approximatively 2 minutes) digital test would be highly helpful to identify patients, who will need a more extensive neuropsychological assessment.

Study Overview

• Status: Completed
• Conditions: HIV-1
• Intervention / Treatment: Other: Classic evaluation of neurocognitive functions; Other: New evaluation of neurocognitive functions

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• France
  • Nice, France, 06001
    • Hôpital Pasteur 2 - Service de Neurologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients infected with HIV-1

Description

Inclusion Criteria:

• Patients infected with HIV-1
• Patients followed in outpatient service, over 18 years of age

Exclusion Criteria:

• Patients infected with HIV-2
• Patients with difficulty understanding the French language
• Patients present with progressive opportunistic infection
• Patients for whom a change of psychotropic treatment was performed in the last 3 weeks
• Patients with drug and / or alcohol addiction
• Patients with a history of psychiatric disorder
• Patients with stroke, endocarditis or meningoencephalitis with severe neurological sequelae

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Absence of cognitive disorder	Other: Classic evaluation of neurocognitive functions; Symbol Digit Modalities Test (SDMT); Other: New evaluation of neurocognitive functions; Cognitive Speed Computerized Test (CSCT)
Asymptomatic cognitive disorder	Other: Classic evaluation of neurocognitive functions; Symbol Digit Modalities Test (SDMT); Other: New evaluation of neurocognitive functions; Cognitive Speed Computerized Test (CSCT)
Symptomatic cognitive impairment	Other: Classic evaluation of neurocognitive functions; Symbol Digit Modalities Test (SDMT); Other: New evaluation of neurocognitive functions; Cognitive Speed Computerized Test (CSCT)
HIV associated dementia	Other: Classic evaluation of neurocognitive functions; Symbol Digit Modalities Test (SDMT); Other: New evaluation of neurocognitive functions; Cognitive Speed Computerized Test (CSCT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Speed Computerized Test (CSCT) score	allows the evaluation of the speed of the processing of the information	at patient inclusion
Montreal Cognitive Assessment (MoCA) Score	allows the evaluation of the overall cognitive functioning	at patient inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paced Auditory Serial Addition Test (PASAT) score	allows to evaluate the concentration capacity	at patient inclusion
Numeric Memory (WAIS-III location and back)	short-term memory evaluation and verbal working memory	at patient inclusion
Score RL-RI16	allows the evaluation of episodic and long-term verbal memory	at patient inclusion
Rey figure	allows the evaluation of the long-term capacities of visio-construction (wealth score) and planning	at patient inclusion
TMTB - TMTA Time Score	Assessment of Mental Flexibility	at patient inclusion
Verbal fluency test	allows the evaluation of the verbal initiation and verbal language capacities	at patient inclusion
IADL score	allows to evaluate the symptomatic character of the disorders	at patient inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2017
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders
• Other Study ID Numbers: 16-PP-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No