NCT01211782

AC-1204 Long-term Efficacy Response Trial (ALERT Protocol)

A Phase 2-3, 6-12 Month, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Daily Administration of AC-1204 in Subjects With Mild to Moderate Alzheimer's Disease Who Are APOE4(-)

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cerecin · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the safety \& efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months. Following the 6 month double-blind phase of the study, subjects may enroll in an optional 6 month open-label extension phase. Efficacy will be evaluated by standard tests of memory and cognition, along with other measurements of activities of daily living and quality of life. Safety will be assessed by frequency of adverse events and changes in laboratory test results. Subjects will be stratified and outcomes will be separately analyzed based on apolipoprotein E4 genotype (APOE4).

Detailed description

Two primary outcome measures will be assessed in APOE4(-) patients: 1. differences from baseline between AC-1204 and placebo groups' ADAS-cog scores at 6 months 2. differences from baseline between AC-1204 and placebo groups' CIBIC+ scores at 6 months Secondary endpoints will include differences between AC-1204 \& placebo groups' scores for these same instruments at 3 months.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	caprylic triglyceride	oral, 20 gm, daily x 6 months
DRUG	long-chain triglyceride	oral, 14 gm, daily x 6 months

Timeline

• First posted: 2010-09-30
• Last updated: 2012-12-04

Locations

1 site across 1 country: United States