A Positron Emission Tomography (PET) Study Evaluating Brain Metabolism of a Medical Food in Alzheimer's Disease

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Dietary Supplement: caprylidene
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: inactive food packet<br> | Dietary Supplement: Placebo<br> <br> |
| Active Comparator: Axona®<br> | Dietary Supplement: caprylidene<br>* Axona® is dosed as a 40g packet mixed into 8 oz of liquid (Ensure) for 45 days<br>* Other names: Axona®, AC-1202;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional cerebral blood flow (rCBF) |  | At baseline | 
| Regional cerebral blood flow (rCBF) |  | 90 minutes after initation of treatment with Axona® | 
| Regional cerebral blood flow (rCBF) |  | 45 days after initation of treatment with Axona® | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition |  | At baseline | 
| To examine the effect of AC-1202 on cognition |  | At baseline | 
| Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition |  | At 90 minutes after initiation of treatment with Axona® | 
| Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition |  | 45 days after initiation of treatment with Axona® | 
| To examine the effect of AC-1202 on cognition |  | At 90 minutes after initiation of treatment with Axona® | 
| To examine the effect of AC-1202 on cognition |  | 45 days after initiation of treatment with Axona® | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dementia