Clinical Outcomes From a Phase 2, Open-Label Study of NE3107 in Patients With Cognitive Decline Due to Degenerative Dementias (P8-6.007)

Abstract

<h3>Objective:</h3> To evaluate the effects of NE3107 on the cognitive performance of patients with dementia using a battery of neuropsychological assessments. <h3>Background:</h3> Alzheimer’s disease (AD) therapeutics targeting amyloid beta and phosphorylated tau have been associated with unclear clinical benefits. Chronic inflammation is thought to induce insulin resistance and promote neurodegenerative proteinopathies to compromise cognition. NE3107 is an oral, blood-brain–permeable molecule that selectively inhibits inflammatory mediators and improves insulin signaling. NE3107 increased insulin sensitivity and restored metabolic homeostasis in patients with type 2 diabetes and inflammation and altered inflammatory biomarkers that have been associated with cognitive decline. We conducted an open-label, phase 2 trial to evaluate the efficacy and safety of NE3107 in patients with dementia. <h3>Design/Methods:</h3> Twenty-three participants were enrolled and received 20-mg oral NE3107 twice daily for 3 months. Participants were 50–89 years old with mild cognitive impairment (MCI) or mild dementia (Quick Dementia Rating Scale [QDRS] cutoff range: 1.5–12.5; Clinical Dementia Rating [CDR] score range: 0.5–1). Cognitive functioning (clinical outcomes) was evaluated at baseline and upon treatment completion using the QDRS, CDR score (estimated by the QDRS), Alzheimer’s Disease Assessment Scale-Cognitive Subscale 12, the Mini-Mental State Examination, and the Montreal Cognitive Assessment. Additionally, participants, caregivers, and clinicians were asked to report a Global Rating of Change. <h3>Results:</h3> Participants had a mean age of 71.6 (SD = 9.63) years and 15 (65%) were females. At baseline, the mean QDRS score was 5.07, 18 (78%) participants had a CDR score of 0.5, and 5 (22%) participants had a CDR score of 1. Results from clinical outcomes will be presented at the conference. <h3>Conclusions:</h3> Using an array of neuropsychological assessments to ascertain changes, this study provides important data on the potential clinical effects and cognitive changes associated with NE3107 administration in individuals with MCI or dementia. <b>Disclosure:</b> Ms. Rindner has nothing to disclose. Ms. Mahdavi has nothing to disclose. Mr. Haroon has nothing to disclose. Ms. Jordan has nothing to disclose. Ms. Zielinski has nothing to disclose. Ms. Venkatraman has nothing to disclose. Mr. Surya has nothing to disclose. Dr. Goodenowe has stock in Prodrome Sciences USA LLC.. Mr. Ahlem has received personal compensation for serving as an employee of Biovie, Inc.. Mr. Ahlem has received personal compensation in the range of $100,000-$499,999 for serving as an officer or member of the Board of Directors for Biovie, Inc.. Mr. Ahlem has received intellectual property interests from a discovery or technology relating to health care. Dr. Reading has received personal compensation for serving as an employee of Biovie, Inc.. Dr. Reading has received intellectual property interests from a discovery or technology relating to health care. Dr. Palumbo has received personal compensation for serving as an employee of BioVie. An immediate family member of Dr. Palumbo has received personal compensation for serving as an employee of Merck Research Laboratories. Dr. Palumbo has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for BioVie. Dr. Palumbo has stock in BioVie. An immediate family member of Dr. Palumbo has stock in Merck Research Laboratories. Dr. Palumbo has received intellectual property interests from a discovery or technology relating to health care. Dr. Palumbo has received intellectual property interests from a discovery or technology relating to health care. Dr. Palumbo has received intellectual property interests from a discovery or technology relating to health care. Dr. POURAT has nothing to disclose. Dr. Jordan has stock in Synaptec Network.