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

Sponsor
University of California, Los Angeles (Other)
Overall Status
Completed
CT.gov ID
NCT01122329
Collaborator
John Douglas French Foundation (Other)
17
Enrollment
2
Locations
2
Arms
51
Duration (Months)
8.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: caprylidene
  • Dietary Supplement: Placebo
 Phase 4

Study Design

Study Type:
Interventional
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 :
Oct 1, 2010
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

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 Names:
  • Axona®, AC-1202

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Regional cerebral blood flow (rCBF) [At baseline]

    2. Regional cerebral blood flow (rCBF) [90 minutes after initation of treatment with Axona®]

    3. Regional cerebral blood flow (rCBF) [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 [At baseline]

    2. To examine the effect of AC-1202 on cognition [At baseline]

    3. Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition [At 90 minutes after initiation of treatment with Axona®]

    4. Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition [45 days after initiation of treatment with Axona®]

    5. To examine the effect of AC-1202 on cognition [At 90 minutes after initiation of treatment with Axona®]

    6. To examine the effect of AC-1202 on cognition [45 days after initiation of treatment with Axona®]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 200 Medical Plaza, UCLA Medical Center Los Angeles California United States 90095
    2 Center for Neurotherapeutics at UCLA 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    Last Update Posted:
    Mar 23, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Joshua Grill, PhD, Assistant Professor, University of California, Los Angeles
    dementia
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Mar 23, 2015