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A Positron Emission Tomography (PET) Study Evaluating Brain Metabolism of a Medical Food in Alzheimer's Disease (AD)

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: NCT01122329
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : March 23, 2015
Sponsor:
Collaborator:
John Douglas French Foundation
Information provided by (Responsible Party):
Joshua Grill, PhD, University of California, Los Angeles

Study Description
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Brief Summary:
This study will examine the brain metabolic effects of AC-1202 (Axona®), a medical food for Alzheimer's disease. Subjects who meet entry criteria will undergo H215O positron emission tomography prior to and 90 minutes after consumption of Axona® at baseline and then again after 45 days of treatment. Cognitive testing will also be conducted at baseline and day 45.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dietary Supplement: caprylidene Dietary Supplement: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Single-site Positron Emission Tomography (PET) Study of the Cerebral Metabolic Effects of AC-1202 (Axona®) Treatment in Mild-to-Moderate Alzheimer's Disease (AD)
Study Start Date : October 2010
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: inactive food packet Dietary Supplement: Placebo
Active Comparator: Axona® Dietary Supplement: caprylidene
Axona® is dosed as a 40g packet mixed into 8 oz of liquid (Ensure) for 45 days
Other Name: Axona®, AC-1202


Outcome Measures
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Primary Outcome Measures :
  1. Regional cerebral blood flow (rCBF) [ Time Frame: At baseline ]
  2. Regional cerebral blood flow (rCBF) [ Time Frame: 90 minutes after initation of treatment with Axona® ]
  3. Regional cerebral blood flow (rCBF) [ Time Frame: 45 days after initation of treatment with Axona® ]

Secondary Outcome Measures :
  1. Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition [ Time Frame: At baseline ]
  2. To examine the effect of AC-1202 on cognition [ Time Frame: At baseline ]
  3. Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition [ Time Frame: At 90 minutes after initiation of treatment with Axona® ]
  4. Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition [ Time Frame: 45 days after initiation of treatment with Axona® ]
  5. To examine the effect of AC-1202 on cognition [ Time Frame: At 90 minutes after initiation of treatment with Axona® ]
  6. To examine the effect of AC-1202 on cognition [ Time Frame: 45 days after initiation of treatment with Axona® ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable AD (NINDS-ADRDA criteria(32))
  • Age 50 - 90 (inclusive)
  • MMSE range: 10 to 28
  • Participants may be taking medications for AD, provided that the dose of these medications has been stable for > 90 days
  • Proficiency in English to be able to perform cognitive tests
  • A caregiver must be available to monitor and administer treatment and to accompany the subject to every clinical visit.

Exclusion Criteria:

  • Inability for any reason to undergo PET/CT scans
  • Previous treatment with AC-1202
  • Allergic to milk or soy
  • Presence of neurodegenerative disease other than AD
  • History of stroke or other injury that could result in cognitive impairment
  • Psychiatric disorder
  • Diabetes mellitus
  • Recent (<90 days) changes to medications prescribed for cognitive reasons or with the potential to impact cognition
  • Irritable bowel syndrome (IBS) or other gastrointestinal conditions that could interfere with treatment compliance
  • Any factor deemed by the investigator to be likely to interfere with study conduction
Contacts and Locations
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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): NCT01122329


Locations
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United States, California
200 Medical Plaza, UCLA Medical Center
Los Angeles, California, United States, 90095
Center for Neurotherapeutics at UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
John Douglas French Foundation
Investigators
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Principal Investigator: Joshua Grill, PhD Mary S. Easton Center for Alzheimer's Disease Research at UCLA
Study Chair: John Ringman, MD Mary S. Easton Center for Alzheimer's Disease Research at UCLA
Study Chair: Maryam Beigi, MD Mary S. Easton Center for Alzheimer's Disease Research at UCLA
Study Chair: Ellen Woo, PhD Mary S. Easton Center for Alzheimer's Disease Research at UCLA
Study Chair: Dan Silverman, MD, PhD UCLA Department of Molecular and Medical Pharmacology
Study Chair: Cathy Lee, PhD Mary S. Easton Center for Alzheimer's Disease Research at UCLA
Study Chair: Jeffrey Cummings, MD Mary S. Easton Center for Alzheimer's Disease Research at UCLA
More Information
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Responsible Party: Joshua Grill, PhD, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01122329    
Other Study ID Numbers: GG-AC-1202
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: March 2015
Keywords provided by Joshua Grill, PhD, University of California, Los Angeles:
dementia
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders