The clinical trial, led by USask College of Medicine professors Dr. Ron Geyer (PhD) and Dr. Andrew Kirk (MD), will advance the development of NeuroEPO, a recombinant form of the naturally produced erythropoietin protein which prevents neuron cell death and promotes the growth and communication of neurons in the brain.
In a prior human clinical study by the Center for Molecular Immunology, NeuroEPO was evaluated in early-stage Alzheimer’s patients and showed:
- More than 80 per cent of the clinical trial participants showed their cognitive decline was arrested, with no further deterioration.
- Cognition improved in 54 per cent of the participants.
- Over 80 per cent of the control group (received placebo) showed worsening in their cognition.
“The positive results that have been demonstrated this far for NeuroEPO are an important milestone in the development of a breakthrough technology for the treatment of Alzheimer’s disease,” Geyer said. “This Phase II clinical trial at the USask will be pivotal towards further demonstrating NeuroEPO’s efficacy, not only for Saskatchewan’s Alzheimer’s patients, but society as a whole."
Members of the clinical research team include assistant professors and geriatricians in the college, Dr. Megan Surkan (MD) and Dr. Krista Lagimodiere (MD), and clinical psychologist Dr. Megan O’Connell (PhD). They will also collaborate with the Centre for Molecular Immunology, who will play an integral role in this trial, as well as with Rocket Science Health Inc.
During the trial, a new method will be used to deliver the drug through the nasal cavity using an engineered drug delivery device developed by Rocket Science Health to deposit small quantities of the drug in the upper nasal region where it is taken directly to the brain without first being metabolized in the liver. This novel direct nose to brain delivery is critical for drug delivery to the brain, which allows NeuroEPO to reach its target in the brain within minutes and avoids the potential for side effects in other organs.
As part of the process to measure the effectiveness of NeuroEPO to stop the decline in cognition in Alzheimer’s patients, the group will use both cognitive assessments and measure biological markers in clinical trial participants that include beta amyloid plaques, Tau neurofibrils and ApoE, as well as MRI that measures decline in brain volume.
These biological markers, which have not previously been measured with NeuroEPO administration, are hallmarks of Alzheimer’s disease and play a significant role in neuron cell death.
Detection of beta amyloid plaques in the brain will be enabled by a positron emission tomography imaging probe (drug) that must be manufactured on-site. Fortunately, the Sylvia Fedoruk Canadian Centre for Nuclear Innovation operates the Saskatchewan Cyclotron Facility on the USask campus to support cutting-edge radiopharmaceutical research and development, such as the work led by Geyer and Kirk. The radiation-emitting component, Fluorine-18, is produced at the Facility and combined with the molecule Flutemetamol, in a laboratory compliant with Health Canada regulations, to yield the imaging probe.
“Establishing a biologic diagnostics process in Saskatchewan will be of great benefit to clinicians, allowing them to more accurately diagnose Alzheimer’s disease and provide the appropriate therapeutic intervention,” Geyer said.
Currently the Alzheimer’s diagnosis is performed using cognitive assessments, making it difficult to differentiate the disease from other types of dementia. The USask team will work with the Geriatric Evaluation and Management Clinic at City Hospital, the Rural and Remote Memory clinic, and the Alzheimer Society of Saskatchewan to recruit participants and make the public aware of this clinical trial.