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

This study is currently recruiting participants.
Verified November 2013 by University of California, Los Angeles
Sponsor:
Collaborator:
John Douglas French Foundation
Information provided by (Responsible Party):
Joshua Grill, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01122329
First received: May 11, 2010
Last updated: November 23, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Alzheimer Disease
Dietary Supplement: caprylidene
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Regional cerebral blood flow (rCBF) [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Regional cerebral blood flow (rCBF) [ Time Frame: 90 minutes after initation of treatment with Axona® ] [ Designated as safety issue: No ]
  • Regional cerebral blood flow (rCBF) [ Time Frame: 45 days after initation of treatment with Axona® ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • To examine the effect of AC-1202 on cognition [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • 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® ] [ Designated as safety issue: No ]
  • Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition [ Time Frame: 45 days after initiation of treatment with Axona® ] [ Designated as safety issue: No ]
  • To examine the effect of AC-1202 on cognition [ Time Frame: At 90 minutes after initiation of treatment with Axona® ] [ Designated as safety issue: No ]
  • To examine the effect of AC-1202 on cognition [ Time Frame: 45 days after initiation of treatment with Axona® ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: October 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122329

Contacts
Contact: Joshua Grill, PhD (310)794-2511 jgrill@mednet.ucla.edu

Locations
United States, California
Center for Neurotherapeutics at UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Joshua Grill, PhD    310-794-2511    jgrill@mednet.ucla.edu   
200 Medical Plaza, UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
John Douglas French Foundation
Investigators
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

No publications provided

Responsible Party: Joshua Grill, PhD, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01122329     History of Changes
Other Study ID Numbers: GG-AC-1202
Study First Received: May 11, 2010
Last Updated: November 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
dementia

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 21, 2014