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

December 3, 2012 updated by: Cerecin

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(-)

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • St. Petersburg, Florida, United States, 33709
        • Meridien Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: long-chain triglyceride
oral, 14 gm, daily x 6 months
Other Names:
  • sunflower oil + maltodextrin
Experimental: AC-1204
Drug: caprylic triglyceride
oral, 20 gm, daily x 6 months
Other Names:
  • AC-1204

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog)
Time Frame: 6 months
change from baseline in ADAS-cog scores at 6 months in APOE4(-) patients
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinicians Interview Based Impression of Change with Caregiver Input (CIBIC+)
Time Frame: 6 months
change from baseline in CIBIC+ scores at 6 months in APOE4(-) patients
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerecin

Investigators

  • Principal Investigator: Mildred Farmer, MD, Meridien Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 24, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 30, 2010

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-10-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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