We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been withdrawn prior to enrollment.
(Study never started. Study was redesgined.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211782
First Posted: September 30, 2010
Last Update Posted: December 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Accera, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Accera, Inc.
ClinicalTrials.gov Identifier: NCT01211782     History of Changes
Other Study ID Numbers: AC-10-006
First Submitted: September 24, 2010
First Posted: September 30, 2010
Last Update Posted: December 4, 2012
Last Verified: December 2012

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
Neurocognitive Disorders
Mental Disorders