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

This study has been withdrawn prior to enrollment.
(Study never started. Study was redesgined.)
Sponsor:
Information provided by (Responsible Party):
Accera, Inc.
ClinicalTrials.gov Identifier:
NCT01211782
First received: September 24, 2010
Last updated: December 3, 2012
Last verified: December 2012
History of Changes

September 24, 2010
December 3, 2012
Not Provided
Not Provided
Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
change from baseline in ADAS-cog scores at 6 months in APOE4(-) patients
Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
change from baseline in ADAS-cog scores at 6 months
Complete list of historical versions of study NCT01211782 on ClinicalTrials.gov Archive Site
Clinicians Interview Based Impression of Change with Caregiver Input (CIBIC+) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
change from baseline in CIBIC+ scores at 6 months in APOE4(-) patients
Clinicians Interview Based Impression of Change with Caregiver Input (CIBIC+) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
change from baseline in CIBIC+ scores at 6 months
Not Provided
Not Provided
 
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(-)

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).

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: caprylic triglyceride
    oral, 20 gm, daily x 6 months
    Other Name: AC-1204
  • Drug: long-chain triglyceride
    oral, 14 gm, daily x 6 months
    Other Name: sunflower oil + maltodextrin
  • Experimental: AC-1204
    Intervention: Drug: caprylic triglyceride
  • Placebo Comparator: Placebo
    Intervention: Drug: long-chain triglyceride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01211782
AC-10-006
No
Accera, Inc.
Accera, Inc.
Not Provided
Principal Investigator: Mildred Farmer, MD Meridien Research
Accera, Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP