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This study has been withdrawn prior to enrollment.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
  Purpose

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).


Condition Intervention Phase
Alzheimer's Disease
Drug: caprylic triglyceride
Drug: long-chain triglyceride
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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(-)

Resource links provided by NLM:


Further study details as provided by Accera, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 0
Arms Assigned Interventions
Experimental: AC-1204 Drug: caprylic triglyceride
oral, 20 gm, daily x 6 months
Other Name: AC-1204
Placebo Comparator: Placebo Drug: long-chain triglyceride
oral, 14 gm, daily x 6 months
Other Name: sunflower oil + maltodextrin

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.
  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211782

Locations
United States, Florida
Meridien Research
St. Petersburg, Florida, United States, 33709
Sponsors and Collaborators
Accera, Inc.
Investigators
Principal Investigator: Mildred Farmer, MD Meridien Research
  More Information

No publications provided

Responsible Party: Accera, Inc.
ClinicalTrials.gov Identifier: NCT01211782     History of Changes
Other Study ID Numbers: AC-10-006
Study First Received: September 24, 2010
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Accera, Inc.:
Alzheimer's disease
AD
AC-1204
ketogenic
ketosis

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014