Neurocognition
Clinical Care and Management (CCM)
About The Study
Study investigators aim to understand the biological, psychological, and social factors that affect brain health, the impact of cognitive symptoms on function and quality of life, and their evolution over time. Researchers are also focused on developing tools that can be applied in the clinic setting. Measurement of cognition remains a major stumbling block to effective brain health management. To address this unmet need, the researchers have developed a brief computerized test (B-CAM, for Brief Cognitive Ability Measure) that applies cutting-edge statistical methods to assess cognition over time. Once optimized as a result of the study, this web-based open-access (meaning, free!) tool could be used in the clinic setting to measure cognitive abilities in a few minutes. Pilot interventional sub-studies aimed at improving brain health are also planned, for which participants in the larger cohort study will be invited to participate.
About The Disease
As life expectancy for people living with HIV increases, it is becoming clear that HIV affects both cognition and mental health, even with excellent systemic viral control. Emerging research suggests that there are multiple interacting processes impacting the brain. Researchers note in particular that antiretroviral therapy (ART) may not fully penetrate the central nervous system, providing a reservoir space for viral replication, and inflammation that may affect brain function. Antiretrovirals may themselves be neurotoxic. Other factors such as aging, depression, cerebrovascular disease, substance abuse and hepatitis C infection may also impact brain health. The experience of living with chronic infection can also threaten brain health by affecting stress levels and physical health. The researchers speculate that, based on data from similar demographics, the prevalence of (primarily mild) cognitive impairment for people living with HIV in Canada is likely to be higher than 30-50% for those over the age of 40.
Study Approach
This is a prospective cohort study seeking to recruit a total of 900 participants. Participants will be assessed and followed at nine-month intervals over a 27 months period for a total of four assessments (five assessments if participant is selected to have neurocognitive evaluation). Clinical assessments will include the measurement of blood pressure, waist and hip circumference, weight, and height as well as the documentation of medical history. Participants will also be asked to complete questionnaires and undergo tests using the B-CAM measurement tool. The researchers hope to further the development of the B-CAM as a free and accessible cognitive assessment tool for routine clinical monitoring of brain health. They are also looking to develop subsequent interventions and mechanism-based studies involving research participants, community members, and those involved in the front line care of people with HIV. This work will provide needed insight into the underlying compromised brain health issues in HIV.
More info on the Brain Health Now study website: brainhealthnow.mcgill.ca
Eligibility Requirements
Required
- Age greater than or equal to 35
- HIV+ for at least 1 year
- Able to communicate adequately in either French or English
- Able to give written informed consent
Not Allowed
- History of chronic kidney disease, osteoporosis, osteopaenia (decrease in bone density)
- History of pathological bone fracture not related to trauma
- Treatment with Interferon, Interleukin, corticosteroids or antiretrovirals
- Treatment which could prevent elimination of the antiretrovirals via the kidneys
- Treatment during the investigation (participation in another trial)
- Administration (during or expected) of a treatment that may be toxic to the kidneys (long-term antiinflammatory)
- Taking intravenous drugs
- A gastro-intestinal disease (or chronic nausea or vomiting) disrupting the absorption of treatments
- Serious disease which could require a treatment that could disrupt the compliance of the treatment
Additional Information
If you would like more information on this clinical study, please refer to a participating site.
Principal Investigators
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Participating Sites
Montreal Chest Institute, McGill University Health Centre
Montreal, QC
Dr. Marie-Josée Brouillette
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