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Accera, Inc. Announces Publication of Results in the Journal Neuropsychiatric Disease and Treatment of a Retrospective Cohort Study Examining the Effects of Axona® in Patients With Mild-to-Moderate Alzheimer's Disease

October 28, 2013

Broomfield, CO, October 28, 2013 – Accera, Inc., a privately-held, commercial-stage, healthcare company focused on the discovery and development of innovative clinical applications to address acute and chronic neurodegenerative diseases, announced today the publication of results in the peer-reviewed open access journal Neuropsychiatric Disease and Treatment. The study, titled "Retrospective Cohort Study of the Efficacy of Caprylic Triglyceride in Patients With Mild-to-Moderate Alzheimer's Disease," involved a retrospective review of medical records for patients taking Axona® a prescription non-drug therapy that addresses a crucial aspect of Alzheimer's disease (AD) known as diminished cerebral glucose metabolism (DCGM). DCGM is characterized by the brain's inability to effectively metabolize glucose, its primary energy source.

Patient outcomes were evaluated by a total of 55 chart reviews conducted at 11 practices in which Axona was prescribed to patients with mild-to-moderate AD for six months or longer. Primary outcome measures for the study were the Physician's Overall Assessment of Patient Status for each individual patient at the most recent assessment on Axona and change in Mini Mental State Exam (MMSE) score at the most recent MMSE assessment on Axona. Secondary measures included changes from baseline in patient's living situation; medication changes for the treatment of AD and for psychiatric symptoms related to AD; changes in patient's memory and ability to carry out instrumental activities of daily living (ADLs) as assessed by caregivers; and adverse events.

Results from the study suggest that administration of Axona in patients with mild-to-moderate AD helped stabilize or improve the clinical status and cognitive function in patients receiving this therapy for an average of approximately 19 months. Physician's Overall Assessment of Changes from baseline indicated that nearly 80% of patients either showed improvement or remained stable. Caregiver assessments also indicated stability or improvement for cognitive function and no significant changes in the ability to carry out ADLs.

Steven Maynard, MD, of the Union Associated Physicians Clinic and Indiana University School of Medicine and lead author of the study, remarked, "Given that diminished cerebral glucose metabolism is a prominent and progressive feature of Alzheimer's disease, these results suggest that administration of Axona can help with the management of symptoms associated with this deficiency in some patients with mild-to-moderate forms of the disease. With a dearth of new and efficacious therapies available to patients and their families, it's important to explore any options that may help improve a patient's cognition and quality of life."

Accera, sponsor of the study, currently markets Axona. In clinical trials, this approach has been shown to safely enhance memory and cognitive function by inducing safe, therapeutic, tolerable and predictable levels of ketosis in patients with mild-to-moderate AD.