Study of Brain Metabolic Effects of Axona®
Purpose
This study will use positron emission tomography (PET) scans to examine the effects of the medical food Axona® 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 medical food product 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 This email address is being protected from spambots. You need JavaScript enabled to view it. to participate in this study or for more information.