On 17 January, the biopharmaceutical company AgeneBio, which develops innovative therapeutics to preserve and restore brain function, announced that it has recruited its first participant in a Phase III clinical trial evaluating AGB101 to treat amnestic Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD). AGB101 has been developed to target the reduction of hippocampal overactivity to slow progression and delay the onset of Alzheimer’s dementia.
The Phase III trial, named “HOPE4MCI”, is a multicenter, randomised, double-blind and placebo-controlled study evaluating the efficacy and safety of AGB101 on slowing progression of MCI due to AD. The trial will enrol 830 participants that will be randomised to receive placebo or the experimental drug AGB101 (220mg) once daily for 78 weeks. Cognitive and functional efficacy will be measured by the Clinical Dementia Ratings Scale – Sum of Boxes (CDR-SB), Mini Mental State Exam (MMSE) and Functional Activities Questionnaire (FAQ). The HOPE4MCI trial also includes a sub-study of specialised imaging to observe the pathology in the brain of the participants. Participants will undergo measures of neurodegeneration (structural MRI, Tau PET).
