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Safety of Caprylic Triglycerides in ALS: A Pilot Study

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.
 
ClinicalTrials.gov Identifier: NCT02716662
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Dale J. Lange, Weill Medical College of Cornell University

Brief Summary:
The purpose of this study is to determine if AC-1204 is safe and tolerated in subjects with ALS. The reason why the investigator wants to use AC-1204 in patients with ALS is to determine if, by taking AC-1204, the body will make substances called ketone bodies. Further, if AC-1204 is well tolerated, the investigators want to change the amount the participant takes, to determine if the amount of ketone bodies in the blood increase in accordance with increases in the amount of AC-1204 the participant takes. The investigators want to do this study because when the investigators gave AC-1204 to mice with ALS, findings suggest the disease course is altered for the better and that the cause of this change is due to the presence of ketones in the blood. If AC-1204 can be proven to be safe and able to cause ketones to increase in the blood, the investigators will likely do subsequent studies to determine if the presence of ketone bodies will slow or stop the progression of the disease. However, this study is not designed to determine if AC-1204 will stop or slow the progression of ALS. It is designed to only determine if patients with ALS can tolerate AC-1204, if ketone bodies are produced and if the amount of ketone bodies produced increases with increasing dose.

Condition or disease Intervention/treatment Phase
ALS Dietary Supplement: Axona Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Caprylic Triglycerides in ALS: A Pilot Study
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : April 25, 2018

Arm Intervention/treatment
Experimental: Open Label
Axona
Dietary Supplement: Axona
medical powder, supplement food
Other Name: AC1204




Primary Outcome Measures :
  1. Ketone levels [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Familial or sporadic ALS diagnosed as probable, laboratory-supported probable or definite according to the World Federation of Neurology El Escorial criteria,
  • Age 18 or older,
  • Capable of providing informed consent and complying with trial procedures,
  • Appel ALS score less than 100,
  • Able to stand on a scale with assistance,
  • Willing to chart food intake during the 12 week study,
  • Patients either not taking Riluzole (Rilutek) or on a stable dose for 30 days or more,
  • Not taking Coenzyme Q10 or on a stable dose and brand for 30 days,
  • Absence of exclusion criteria.

Exclusion Criteria:

  • Forced vital capacity <40% of predicted,
  • Dependence on mechanical ventilation for more than 12 hours per day,
  • Exposure to any experimental agent within 30 days of entry or at any time during the trial,
  • Women who are breastfeeding, who are pregnant or are planning to become pregnant,
  • Women of childbearing potential not practicing a medically accepted form of contraception,
  • Enrollment in another research study within 30 days of or during this trial,
  • Mini-Mental State Exam (MMSE) score <20,
  • Patients with symptomatic cardiac disease or hypercholesterolemia,
  • Patients with myocardial infarction within 6 months of this trial,
  • Renal dysfunction defined as BUN and creatinine >2xULN,
  • Known mitochondrial disease,
  • BMI<18.5,
  • Prior use of a 4:1 ketogenic diet or Atkins diet within 1 month of this trial,
  • Impaired liver function, defined as AST or ALT of 3xULN,
  • Patients who have a pacemaker or other internal electronic medical device,
  • Known allergy or hypersensitivity to milk or soy products.

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): NCT02716662


Locations
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United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
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Responsible Party: Dr. Dale J. Lange, MD, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02716662    
Other Study ID Numbers: 1307014081
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018