MedTrace Logo

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

NCT01211782 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2012-12-04

No results posted yet for this study

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).

Conditions

Interventions

DRUG

caprylic triglyceride

oral, 20 gm, daily x 6 months

DRUG

long-chain triglyceride

oral, 14 gm, daily x 6 months

Sponsors & Collaborators

  • Cerecin

    lead INDUSTRY

Principal Investigators

  • Mildred Farmer, MD · Meridien Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01211782 on ClinicalTrials.gov