The ART-NECO study;Long term effective combination antiretroviral therapy (cART) and its effect on neurocognition. A prospective cohort study to assess the feasibility of two short cognitive screen tests in patients infected with HIV1 and the development of neurocognitive impairment over time

An increasing number of papers report on cognitive deficits in HIV seropositive
patients even during long-term successful treatment with combination
antiretroviral therapy (cART).
Limited penetration of antiretroviral (ARV) drugs into the brain and ongoing
viral replication followed by insidious damage of the brain is supposed to be a
major factor for the development of neurocognitive impairment in HIV patients.
Besides, many other factors like age, co infections, and comorbidities are
supposed to be involved.
It can be expected that in future cognitive disfunction may occur more often
in HIV1 seropositive patients, particularly with growing age.
The clinical significance of cognitive deficits however is not exactly known.
Furthermore a short cognitive screening test for detection of cognitive
deficits is highly warranted in clinical practice, as extensive
neuropsychological tests are not attainable in this setting.
The international aids dementia scale (ADS) is recommended in literature to
assess cognitive dysfunction. But this test is not appropriate for detection of
mild-to moderate cognitive disorders. The Montreal Cognitive Assesment also can
be used, but has not been investigated in HIV seropositive patients.
The present study proposal seeks to investigate the utility of and to compare
the three different sets of cognitive function tests (i.e extensive
neuropsychological assessment, the international Aids Dementia scale and the
MoCa) in a Dutch cohort of HIV infected patients on chronic effective
combination antiretroviral therapy. The second aim is to corellate cognitive
impairment to structural brain abnormalities, visualized by MRI.

To examine neurocognition in 100 HIV1 seropositive patients on chronic
effective cART using three different tests: the Montreal cognitive assessment
(MoCA) , the International Aids Dementia scale (ADS) and extensive
neuropsychological testing of five domains.
- To establish the utility of MoCA and ADS as screening tests for cognitive
function
- To determine the course of cognitive functioning over a 1-year period;
- To establish the relation between HIV-associated neurocognitive disorders and
quality of life, subjective well-being and subjective cognitive complaints.
- To establish the incidence of structural brain abormalities on MRI

One hundred HIV 1 seropositive patients on chronic effective cART will be
recruited for this study. After informed consent an extensive
neuropsychological test (appendix 1) , the ADS (appendix 2) and the MoCA
(appendix 3) will be performed. A depression scale and a questionnaire on
quality of life and a MRI of the brain will be done as well. The
neuropsychological examination will include the following domains: memory,
attention and concentration, executive functioning, motor function, processing
speed and visual construction.

Furthermore, an MRI of the brain will be made

The neuropsychological assessments will be repeated after one year. Slight
modifications will be brought into the test batteries in order to prevent a
learning effect. The reliable change index (RCI) will be calculated as a
correction for a potential learning effect. Symptom validity and psychosocial
variables will be taken into account.

Neuropsychological test
MRI cerebrum
Lumbar puncture(s)
Blood punctures

2-3 extra hospital-visits