AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext

Phase 2/3 Completed 418 enrolled Cerecin

RandomizedParallel-groupQuadruple-blindSupportive care

Summary

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.

Timeline

Start: 2013-03
Primary completion: 2016-10-24
Completion: 2017-04-14

Outcome

Missed primary endpoint

paper LS differences of mean - 0.761, p = 0.2458 PMID 32310169 ↗

paper The AC-1204 formulation of caprylic triglyceride failed to improve cognition or functional ability in subjects with mild-to-moderate AD. PMID 32310169 ↗

Publications

Henderson ST, Morimoto BH, Cummings JL, Farlow MR, Walker J. A Placebo-Controlled, Parallel-Group, Randomized Clinical Trial of AC-1204 in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2020;75(2):547-557. doi: 10.3233/JAD-191302.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tricaprilin	Other / unclassified	20 g	Oral