A Positron Emission Tomography (PET) Study Evaluating Brain Metabolism of a Medical Food in Alzheimer's Disease
Completed · Phase 4 · Has a placebo group
Conditions studied: Alzheimer Disease
In brief
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.
Key facts
- Study ID
- NCT01122329
- Run by
- University of California, Los Angeles
- People needed
- 17
- Starts
- 2010-10-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2015-03-23
Who can join
Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- 200 Medical Plaza, UCLA Medical Center — Los Angeles, California, United States
- Center for Neurotherapeutics at UCLA — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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