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

Phase 2

Withdrawn

• Conditions: Alzheimer's Disease
• Interventions: Drug: long-chain triglyceride; Drug: caprylic triglyceride

• Registration Number: NCT01211782
• Lead Sponsor: Cerecin

Brief 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.

Study Timeline

• Study First Submitted: 2010-09-24
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-30
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-03
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Males/females between age of 55 -85 years
• MMSE scores between 16-26
• Probable mild to moderate AD

Exclusion Criteria

• Presence of other CNS disorders as alternative causes of dementia
• Type 1 or Type 2 diabetes
• Significant renal/hepatic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	long-chain triglyceride	-
AC-1204	caprylic triglyceride	-

Primary Outcome Measures

Name	Time	Method
Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog)	6 months	change from baseline in ADAS-cog scores at 6 months in APOE4(-) patients

Secondary Outcome Measures

Name	Time	Method
Clinicians Interview Based Impression of Change with Caregiver Input (CIBIC+)	6 months	change from baseline in CIBIC+ scores at 6 months in APOE4(-) patients

Trial Locations

Locations (1)

Meridien Research; 🇺🇸 St. Petersburg, Florida, United States