Deep Brain Stimulation of the Fornix in Alzheimer’s Disease: Investigations into clinical and imaging biomarkers and dose optimization
Toronto General Hospital & Toronto Western Hospital
This is a prospective, open-label trial designed to study the effect of brain stimulation on CSF and brain amyloid pathology in AD. In addition, patients will undergo neuropsychological testing at various stimulation settings to help determine optimal stimulation parameters.
All subjects will be followed to a common closing date, which will be at the time the last subject enrolled is followed for 12 months. Clinical follow up with neurology and neurosurgery will be offered for the patient’s lifetime.
Relevance to the acceleration of therapeutics for neurodegenerative diseases of aging
The significance of this study is two-fold: 1) A possible demonstration that DBS may directly influence brain pathology in AD as measure by amyloid imaging and CSF protein changes, hence providing a mechanism of action for its clinical effects, and 2) the first study to empirically determine, using a memory task, the optimal stimulation parameters for DBS patients to improve memory function.
To evaluate the influence of deep brain stimulation in Alzheimer’s Disease on markers of AD pathology in cerebrospinal fluid (CSF) and on neuroimaging with positron emission tomography (PET) and to optimize electrical stimulation parameters.