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

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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 August 20, 2014