Date: 2015-07-14
Type of information: update on patient enrollment
phase: 2-3
Announcement: update on patient enrollment
Company: Accera (USA - CO)
Product: AC-1204 (caprylic triglyceride)
Action mechanism:
Disease: Alzheimer\'s disease
Therapeutic area: Neurodegenerative diseases
Country: USA
Trial
details: NOURISH AD is a 26-week, double-blind, randomized, placebo-controlled, parallel-group study investigating the effects of daily administration of AC-1204 in subjects with mild to moderate Alzheimer’s disease, with an optional 26-week open-label extension.
This study will evaluate the effects of daily dosing of AC-1204 on cognition, activities of daily living, resource utilization, quality of life, pharmacokinetic measures and safety among participants with mild to moderate Alzheimer\'s Disease. (NCT01741194)
Latest
news: * On July 14, 2015, Accera announced that it has achieved 75% enrollment for its NOURISH AD Phase 3 clinical study of AC-1204 for the treatment of Alzheimer’s disease. The study has a total planned enrollment of approximately 480 patients and is the first of two Phase 3 trials of AC-1204, an investigational new drug designed to address the metabolic defect of the brain observed in Alzheimer’s patients. Conducted at up to 90 sites, the study is currently enrolling patients with an anticipated total of approximately 480 enrolled. The primary and key secondary endpoints will examine the effects of AC-1204 on memory and cognition as measured by the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-Cog) and global function as measured by the Alzheimer’s Disease Study Cooperative Study – Clinicial Global Impression of Change (ADCS-CGIC) after 26 weeks among non-carriers of the epsilon 4 variant of the gene apolipoprotein E (APOE4). The study will also evaluate activities of daily living, resource utilization and quality of life among subjects with mild-to-moderate Alzheimer’s.
