Brain Chemistry Design

Clinical Trials

     Apathy and agitation are among the most common comorbidities associated with dementia, placing great stress on caregivers and families. NAB-IT, Cerevel, and S-CitAD are clinical trials aimed at reducing these neuropsychiatric symptoms, and thus, improving the quality of life of patients and their caregivers.

     Cerevel is a randomized, double-blind, placebo-controlled trial that evaluates the safety, tolerability, and pharmacodynamics of CVL-871 in patients with dementia-related apathy. CVL-871 is a selective partial agonist of dopamine D1/D5 receptors. This mechanism may be useful in modulating the complex neural networks that govern cognition, motivation, and behavior, which are impaired in dementia. Participants will be randomized to receive either CVL-871, or a placebo for 12-weeks. This medication regimen will be followed by 4 weeks of follow up, including neurological exams, blood and urine tests, and electrocardiograms.

     The Medical Imaging Trial NEtwork of Canada (MITNEC) study looks at the usefulness of imaging and genetic tests with measurements of memory and thinking, for the identification and treatment of white matter (WM) disease in patients with cognitive impairment related to Alzheimer’s (AD) or WM disease.

     Two groups of people participate in this study: (1) individuals with AD and WM disease and (2) individuals who have had a stroke or a transient ischemic attack. By using advanced brain imaging techniques, we will compare changes in the brain over a 2-year period. Participation may involve up to 6 study visits, as well as telephone contacts over the next 24 months.

     This study is funded by Sunnybrook Foundation and in-kind support by Avid Radiopharmaceuticals.

     Apathy and agitation are among the most common comorbidities associated with dementia, placing great stress on caregivers and families. NAB-IT, Cerevel, and S-CitAD are clinical trials aimed at reducing these neuropsychiatric symptoms, and thus, improving the quality of life of patients and their caregivers.

     The Nabilone for Agitation Blinded Intervention Trial (NAB-IT) is a phase III, multi-centre, double-blind, randomized, placebo-controlled trial assessing the effect of nabilone on reducing agitation in Alzheimer's disease (AD). Nabilone is a synthetic cannabinoid that may exert neuroprotective effects by modulating neuroinflammation and oxidative stress, which are hallmarks of AD. Participants in this study will be randomized to receive either nabilone or a placebo for 8 weeks. In addition to assessing effectiveness of nabilone in treating agitation, other relevant outcomes, such as other behavioural symptoms, cognition, weight, nutritional status, and pain, will be assessed.

     The purpose of the Randomized, Open Label, Proof of Concept Study of Telmisartan vs. Perindopril in Hypertensive Mild-Moderate Alzheimer’s Disease Patients (SARTAN-AD) study is to determine whether there is any difference between the effects of two commonly used medications, telmisartan and perindopril, in patients who have Alzheimer’s disease (AD). The study aims to determine if these drugs provide a benefit to AD patients by slowing down how the brain is changing.

     The two medications are currently approved by Health Canada for treating high blood pressure and for prevention of heart disease, stroke, and kidney disease in patients both with and without high blood pressure. Recent scientific evidence suggests these medications may be also be beneficial in preventing or slowing down Alzheimer’s disease.

     Participants in this study will be randomly placed in one of two treatment groups – one group will take perindopril, while the other group will take telmisartan. The assigned drug will be taken for one year.

     This study is sponsored by Sunnybrook Research Institute and funded by the Alzheimer Drug Discovery Foundation (ADDF) Canada and the Weston Brain Institute.

     Apathy and agitation are among the most common comorbidities associated with dementia, placing great stress on caregivers and families. NAB-IT, Cerevel, and S-CitAD are clinical trials aimed at reducing these neuropsychiatric symptoms, and thus, improving the quality of life of patients and their caregivers.

     Escitalopram for Agitation in Alzheimer’s Disease (S-CitAD) is a multi-centre, placebo-controlled, masked, randomized clinical trial, designed to examine the efficacy and safety of escitalopram (an antidepressant) in combination with a psychosocial intervention (PSI) as treatment for agitation in Alzheimer's dementia patients. Participants with clinically significant agitation, and their caregiver(s), will receive a structured PSI. If there is no response in three weeks, they will be provided a study drug (escitalopram or a matching placebo) for 12 weeks, with in-person and remote (phone/video) visits at weeks 3, 6, 9, and 12, and with telephone contacts in between.

     The Trial of Remote Ischemic Pre-Conditioning in Vascular Cognitive Impairment (TRIC-VCI) study is led by Dr. Eric Smith. It is a multi-centre, prospective, randomized, open label and blinded end-point trial investigating whether remote ischemic conditioning (RIC) is feasible, safe, and tolerable in patients with vascular cognitive impairment caused by cerebral small vessel disease. The study is researching whether the RIC device can improve blood flow to the brain and hopefully might improve memory and concentration by preventing silent strokes. The TRIC-VCI study has a 90-day study duration with cognitive testing, blood draws and MRI at randomization 30 and 90 days.