Clinical trial NCT01122329: A Positron Emission Tomography (PET) Study Evaluating Brain Metabolism of a Medical Food in Alzheimer's Disease
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer Disease
Keywords: dementia
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: John Douglas French Foundation
First posted: 2010-05-13
Enrollment: 17
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Regional cerebral blood flow (rCBF)
timeFrame: At baseline
measure: Regional cerebral blood flow (rCBF)
timeFrame: 90 minutes after initation of treatment with Axona®
measure: Regional cerebral blood flow (rCBF)
timeFrame: 45 days after initation of treatment with Axona®
Secondary outcomes:
measure: Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition
timeFrame: At baseline
measure: To examine the effect of AC-1202 on cognition
timeFrame: At baseline
measure: Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition
timeFrame: At 90 minutes after initiation of treatment with Axona®
measure: Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition
timeFrame: 45 days after initiation of treatment with Axona®
measure: To examine the effect of AC-1202 on cognition
timeFrame: At 90 minutes after initiation of treatment with Axona®
measure: To examine the effect of AC-1202 on cognition
timeFrame: 45 days after initiation of treatment with Axona®
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: 200 Medical Plaza, UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: Center for Neurotherapeutics at UCLA
state: California
Study officials:
affiliation: Mary S. Easton Center for Alzheimer's Disease Research at UCLA
name: Joshua Grill, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mary S. Easton Center for Alzheimer's Disease Research at UCLA
name: John Ringman, MD
role: STUDY_CHAIR
affiliation: Mary S. Easton Center for Alzheimer's Disease Research at UCLA
name: Maryam Beigi, MD
role: STUDY_CHAIR
affiliation: Mary S. Easton Center for Alzheimer's Disease Research at UCLA
name: Ellen Woo, PhD
role: STUDY_CHAIR
affiliation: UCLA Department of Molecular and Medical Pharmacology
name: Dan Silverman, MD, PhD
role: STUDY_CHAIR
affiliation: Mary S. Easton Center for Alzheimer's Disease Research at UCLA
name: Cathy Lee, PhD
role: STUDY_CHAIR
affiliation: Mary S. Easton Center for Alzheimer's Disease Research at UCLA
name: Jeffrey Cummings, MD
role: STUDY_CHAIR
References: