AZ Therapies has announced that the Phase 3 COGNITE study of ALZT-OP1 inhaled cromolyn/oral ibuprofen for the treatment of early stage Alzheimer’s disease has completed enrollment. The company, which announced the initiation of the study in September 2015, said that it has a special protocol assessment (SPA) agreement with the FDA regarding the trial design.
Approximately 1,800 Alzheimer’s patients aged 55-79 were screened by cognition, function, and levels of biomarkers in cerebrospinal fluid to enroll 620 patients, according to the company, “to ensure homogeneous staging of early Alzheimer’s patients in the clinical trial.”
AZTherapies Founder, CEO, and Chairman David R. Elmaleh said, “ALZT-OP1 uses a novel multi-modal approach that includes attacking the neuroinflammation that leads to neuronal death. By attempting to enhance the brain’s microglial immune cells’ neuroprotective activity and inhibit pro-inflammatory cytokine production, we aim to halt or slow the progression of Alzheimer’s disease in its early stages. ALZT-OP1 is a proprietary combination of two previously approved small molecules that have been re-engineered to provide a daily dose to suppress the brain’s neuroinflammatory response. With the COGNITE trial now fully enrolled, we are one step closer to providing Alzheimer’s patients with new hope for a treatment and look forward to completing the trial in late 2020.”
AZTherapies Scientific Advisory Board member Martin Farlow, Professor Emeritus of Neurology at Indiana University School of Medicine, added, “I am encouraged by the continued progress in this clinical trial. This trial encompasses a number of unique features, including the narrow age spread of patients, the early stage of disease, and the battery of cognition, function, and the CSF measures included, which may shed light on disease progression. A positive outcome in this study could be a meaningful breakthrough in the treatment of early Alzheimer’s disease, validating the role that neuroinflammation plays in neurodegeneration and positioning ALZT-OP1 as a promising new option for the millions of people living with Alzheimer’s disease.”
Read the AZTherapies press release.
