HIV-1NEURACogNCT03279835
Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients
An observational study of HIV-1, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1
- What is being tested?
- Classic evaluation of neurocognitive functions and New evaluation of neurocognitive functions
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2017to 30 Oct 2018
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients infected with HIV-1
Who may be able to join
- Patients infected with HIV-1
- Patients followed in outpatient service, over 18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- HIV-1
- Being tested
- Classic evaluation of neurocognitive functions, New evaluation of neurocognitive functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic evaluation of neurocognitive functionsOther
Symbol Digit Modalities Test (SDMT)
New evaluation of neurocognitive functionsOther
Cognitive Speed Computerized Test (CSCT)
| Study group | Role | What they receive |
|---|---|---|
| Absence of cognitive disorder | Not described Receives: Other: Classic evaluation of neurocognitive functions; Other: New evaluation of neurocognitive functions | |
| Asymptomatic cognitive disorder | Not described Receives: Other: Classic evaluation of neurocognitive functions; Other: New evaluation of neurocognitive functions | |
| Symptomatic cognitive impairment | Not described Receives: Other: Classic evaluation of neurocognitive functions; Other: New evaluation of neurocognitive functions | |
| HIV associated dementia | Not described Receives: Other: Classic evaluation of neurocognitive functions; Other: New evaluation of neurocognitive functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Speed Computerized Test (CSCT) score
allows the evaluation of the speed of the processing of the information
Measured: at patient inclusion
Montreal Cognitive Assessment (MoCA) Score
allows the evaluation of the overall cognitive functioning
Measured: at patient inclusion
Secondary outcomes (7)
Paced Auditory Serial Addition Test (PASAT) score
allows to evaluate the concentration capacity
Measured: at patient inclusion
Numeric Memory (WAIS-III location and back)
short-term memory evaluation and verbal working memory
Measured: at patient inclusion
Score RL-RI16
allows the evaluation of episodic and long-term verbal memory
Measured: at patient inclusion
Rey figure
allows the evaluation of the long-term capacities of visio-construction (wealth score) and planning
Measured: at patient inclusion
TMTB - TMTA Time Score
Assessment of Mental Flexibility
Measured: at patient inclusion
Verbal fluency test
allows the evaluation of the verbal initiation and verbal language capacities
Measured: at patient inclusion
IADL score
allows to evaluate the symptomatic character of the disorders
Measured: at patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start16 Mar 2017
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279835
- Sponsor's protocol ID
- 16-PP-09
- Acronym
- NEURACog
- Status last verified
- May 2019
- First submitted
- 7 Sep 2017
- Last updated
- 20 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients
- ClinicalTrials.gov ID
- NCT03279835
- Acronym / sponsor ID
- NEURACog / 16-PP-09
- Conditions
- HIV-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 12 Sep 2017 (actual)
- 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Absence of cognitive disorder | – | Other: Classic evaluation of neurocognitive functions, Other: New evaluation of neurocognitive functions |
| Asymptomatic cognitive disorder | – | Other: Classic evaluation of neurocognitive functions, Other: New evaluation of neurocognitive functions |
| Symptomatic cognitive impairment | – | Other: Classic evaluation of neurocognitive functions, Other: New evaluation of neurocognitive functions |
| HIV associated dementia | – | Other: Classic evaluation of neurocognitive functions, Other: New evaluation of neurocognitive functions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients infected with HIV-1
Key inclusion criteria (2 listed)
- Patients infected with HIV-1
- Patients followed in outpatient service, over 18 years of age
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classic evaluation of neurocognitive functionsSymbol Digit Modalities Test (SDMT) | Other | Absence of cognitive disorder, Asymptomatic cognitive disorder, HIV associated dementia, Symptomatic cognitive impairment |
| New evaluation of neurocognitive functionsCognitive Speed Computerized Test (CSCT) | Other | Absence of cognitive disorder, Asymptomatic cognitive disorder, HIV associated dementia, Symptomatic cognitive impairment |
Primary outcome
Cognitive Speed Computerized Test (CSCT) score
Time frame: at patient inclusion
allows the evaluation of the speed of the processing of the information
Montreal Cognitive Assessment (MoCA) Score
Time frame: at patient inclusion
allows the evaluation of the overall cognitive functioning
7 secondary outcomes
Paced Auditory Serial Addition Test (PASAT) score
Time frame: at patient inclusion
Numeric Memory (WAIS-III location and back)
Time frame: at patient inclusion
Score RL-RI16
Time frame: at patient inclusion
Rey figure
Time frame: at patient inclusion
TMTB - TMTA Time Score
Time frame: at patient inclusion
Verbal fluency test
Time frame: at patient inclusion
IADL score
Time frame: at patient inclusion
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 20 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-1, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 7 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 20 May 2019. 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 France. 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?
Cognitive Speed Computerized Test (CSCT) score (time frame: at patient inclusion). The study lists 2 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 20 May 2019.