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



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 90
Updated:3/16/2015
Start Date:October 2010
End Date:June 2014
Contact:Joshua Grill, PhD
Email:jgrill@mednet.ucla.edu
Phone:(310)794-2511

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
2
sites
200 Medical Plaza, UCLA Medical Center
Los Angeles, California 90095
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Center for Neurotherapeutics at UCLA
Los Angeles, California 90095
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Los Angeles, CA
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