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Study of Brain Metabolic Effects of Axona®

Purpose

This study will use positron emission tomography (PET) scans to examine the effects of Axona®, a substance containing medium chain triglycerides, on blood flow to the brain in patients with Alzheimer’s disease (AD). The study involves 3 visits to the clinic over the course of 45 days. 90% of participants in this study will receive the active substance and 10% of participants will receive a placebo (inactive product). Participants will be examined by a doctor as well as partake in cognitive testing, blood draws, and PET scans. Potential side effects of participating in this study are generally mild and will be carefully monitored throughout the study. To be eligible for this study, one must be diagnosed with Alzheimer’s disease, between 50 and 90 years old, and in good health. For more information, please call the UCLA Easton Alzheimer's Disease Center at (310) 794-6039 or This email address is being protected from spambots. You need JavaScript enabled to view it. .

Sponsor: University of California, Los Angeles
Collaborator: John Douglas French Foundation
ClinicalTrials.gov Identifier: NCT01122329

Condition: Intervention: Phase:
Alzheimer's Disease Dietary Supplement: caprylidene Phase IV

Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, 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)
Length of Study: 45 Days
Number of Visits: 3 Visits
Estimated Enrollment: 22
Eligibility
Ages Eligible for Study: 50 Years to 90 Years
Genders Eligible for Study: Both
Criteria

Inclusion Criteria:

Diagnosis of probable AD (NINDS-ADRDA criteria(32))
Age 50 - 90 (inclusive)
MMSE range: 14 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

Contact: Doug Hawkins at (310) 794-6039 or This email address is being protected from spambots. You need JavaScript enabled to view it. to participate in this study or for more information.