IGC Announces FDA Removal of Clinical Hold for Multiple Ascending Dose Study of IGC-AD1, Targeting Patients Suffering from Alzheimer’s-related Dementia
(FDA) notified IGC that it has authorized the Company to initiate a Phase 1 human trial study for the Company’s investigational cannabinoid formulation for the treatment of patients suffering from mild to severe dementia due to Alzheimer’s disease.
After the completion of administrative tasks, the Company plans to begin enrolling patients suffering from Alzheimer’s-related dementia for a 12-subject safety Multiple Ascending Dose (MAD) Study. The Company believes that the FDA’s approval of the initiation of the Phase 1 trial is a significant next step in IGC’s efforts to develop a potential therapy for treating patients suffering from a devastating disease.
"We believe that this a first human trail of this sort,"
Currently, there is no cure for Alzheimer’s disease.