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

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)

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: caprylidene

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • 200 Medical Plaza, UCLA Medical Center
    • Los Angeles, California, United States, 90095
      • Center for Neurotherapeutics at UCLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Regional cerebral blood flow (rCBF)	At baseline
Regional cerebral blood flow (rCBF)	90 minutes after initation of treatment with Axona®
Regional cerebral blood flow (rCBF)	45 days after initation of treatment with Axona®

Secondary Outcome Measures

Outcome Measure	Time Frame
Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition	At baseline
To examine the effect of AC-1202 on cognition	At baseline
Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition	At 90 minutes after initiation of treatment with Axona®
Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition	45 days after initiation of treatment with Axona®
To examine the effect of AC-1202 on cognition	At 90 minutes after initiation of treatment with Axona®
To examine the effect of AC-1202 on cognition	45 days after initiation of treatment with Axona®

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: 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 record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 11, 2010
• First Submitted That Met QC Criteria: May 12, 2010
• First Posted (Estimate): May 13, 2010

Study Record Updates

• Last Update Posted (Estimate): March 23, 2015
• Last Update Submitted That Met QC Criteria: March 19, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: dementia
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: GG-AC-1202