This study will examine the brain metabolic effects of AC-1202 (Axona®),
This study will examine the brain metabolic effects of AC-1202 (Axona®),
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http://clinicaltrials.gov/ct2/show/NCT01122329
A Positron Emission Tomography (PET) Study Evaluating Brain Metabolism of a Medical Food in Alzheimer's Disease (AD)
This study is currently recruiting participants.
Verified October 2010 by University of California, Los Angeles
First Received on May 11, 2010. Last Updated on October 21, 2011 History of Changes
| Sponsor: | University of California, Los Angeles |
|---|---|
| Collaborator: | John Douglas French Foundation |
| Information provided by: | University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01122329 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Alzheimer Disease |
Dietary Supplement: caprylidene Dietary Supplement: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: |
Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: 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) |
Resource links provided by NLM:
Genetics Home Reference related topics: Alzheimer disease
U.S. FDA Resources
Further study details as provided by University of California, Los Angeles:
Primary Outcome Measures:
- Regional cerebral blood flow (rCBF) [ Time Frame: At baseline ] [ Designated as safety issue: No ]
- Regional cerebral blood flow (rCBF) [ Time Frame: 90 minutes after initation of treatment with Axona® ] [ Designated as safety issue: No ]
- Regional cerebral blood flow (rCBF) [ Time Frame: 45 days after initation of treatment with Axona® ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition [ Time Frame: At baseline ] [ Designated as safety issue: No ]
- To examine the effect of AC-1202 on cognition [ Time Frame: At baseline ] [ Designated as safety issue: No ]
- Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition [ Time Frame: At 90 minutes after initiation of treatment with Axona® ] [ Designated as safety issue: No ]
- Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition [ Time Frame: 45 days after initiation of treatment with Axona® ] [ Designated as safety issue: No ]
- To examine the effect of AC-1202 on cognition [ Time Frame: At 90 minutes after initiation of treatment with Axona® ] [ Designated as safety issue: No ]
- To examine the effect of AC-1202 on cognition [ Time Frame: 45 days after initiation of treatment with Axona® ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 22 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: inactive food packet | Dietary Supplement: Placebo |
| Active Comparator: Axona® |
Dietary Supplement: caprylidene
Axona® is dosed as a 40g packet mixed into 8 oz of liquid (Ensure) for 45 days
Other Name: Axona®, AC-1202
|
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122329
Contacts
| Contact: Joshua Grill, PhD | (310)794-2511 | jgrill@mednet.ucla.edu |
Locations
| United States, California | |
| The Deane F. Johnson Center for Neurotherapeutics at UCLA | Recruiting |
| Los Angeles, California, United States, 90095 | |
| 200 Medical Plaza, UCLA Medical Center | Recruiting |
| Los Angeles, California, United States, 90095 | |
Sponsors and Collaborators
University of California, Los Angeles
John Douglas French Foundation
Investigators
| Principal Investigator: | Joshua Grill, PhD | Mary S. Easton Center for Alzheimer's Disease Research at UCLA |
| Study Chair: | John Ringman, MD | Mary S. Easton Center for Alzheimer's Disease Research at UCLA |
| Study Chair: | Maryam Beigi, MD | Mary S. Easton Center for Alzheimer's Disease Research at UCLA |
| Study Chair: | Ellen Woo, PhD | Mary S. Easton Center for Alzheimer's Disease Research at UCLA |
| Study Chair: | Dan Silverman, MD, PhD | UCLA Department of Molecular and Medical Pharmacology |
| Study Chair: | Cathy Lee, PhD | Mary S. Easton Center for Alzheimer's Disease Research at UCLA |
| Study Chair: | Jeffrey Cummings, MD | Mary S. Easton Center for Alzheimer's Disease Research at UCLA |
More Information
No publications provided
| Responsible Party: | Joshua Grill, PhD, Mary S. Easton Center for Alzheimer's Disease Research at UCLA |
| ClinicalTrials.gov Identifier: | NCT01122329 History of Changes |
| Other Study ID Numbers: | GG-AC-1202 |
| Study First Received: | May 11, 2010 |
| Last Updated: | October 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Los Angeles:
| dementia |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on February 14, 2012
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