AgeneBio Announces Completion of Patient Enrollment in Phase 2B Clinical Trial to Evaluate AGB101 to Treat Amnestic Mild Cognitive Impairment Due to Alzheimer's Disease
BALTIMORE, April 21, 2021 /PRNewswire/ -- AgeneBio announced today that it has completed enrollment in a Phase 2B clinical trial evaluating the efficacy of AGB101, a once-a-day investigational medication to treat amnestic Mild Cognitive Impairment due to Alzheimer's Disease (MCI due to AD). The clinical trial, known as "HOPE4MCI" (NCT03486938), is a 78-week study, randomized, double-blind, placebo controlled study that has enrolled 164 patients across 23 sites in the United States and Canada.
Accumulated evidence has demonstrated that neural overactivity drives both amyloid and tau pathology in brain. The HOPE4MCI study builds on an earlier trial1 that demonstrated the efficacy of AGB101 to reduce hippocampal overactivity and improve episodic memory. Cognitive and functional efficacy in the HOPE4MCI study will be measured by the Clinical Dementia Ratings Scale – Sum of Boxes (CDR-SB) (primary endpoint), Mini Mental State Exam and Functional Activities Questionnaire (MMSE, FAQ). The CDR-SB has been recognized by the FDA as an appropriate endpoint for potential registration trials.
The HOPE4MCI trial also includes a sub-study of brain PET imaging to track measures of neurodegeneration (structural MRI, Tau PET). The use of [18F]MK-6240 scanning for tau, developed by Cerveau Technologies, together with a structural brain analysis developed in collaboration with the Johns Hopkins Center for Imaging Science and Bioclinica, will trace the spread of pathology over the length of the clinical protocol and its potential modification by therapeutic treatment.
"The scale of interest that we've seen in this trial, even as patients and their doctors navigate unprecedented challenges posed by the global pandemic, underlines the urgency of unmet needs in Alzheimer's research," said Sharon Rosenzweig-Lipson, Vice President of Research and Development for AgeneBio.
"As the population continues to age, the need for approved treatment options for Alzheimer's Disease will become even more critical," said Richard Mohs, Vice President of Clinical Development for AgeneBio and Principal Investigator for HOPE4MCI. "We are thrilled with the progress of the trial and are looking forward to sharing our results at the end of next year."
Cautionary Note Regarding Forward-Looking Statements
Disclosure: Research reported in this publication was supported by the National Institute On Aging of the National Institutes of Health under Award Number R01AG061091. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
1 ClinicalTrials.gov. John Hopkins University. (2017, August 21). Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI). Identifier NCT01044758. Retrieved from: https://clinicaltrials.gov/ct2/show/study/NCT01044758?term=levetiracetam%2C+alzheimer%27s&rank=5.
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