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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-01-31

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.

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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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inactive food packet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Axona®

Group Type ACTIVE_COMPARATOR

caprylidene

Intervention Type DIETARY_SUPPLEMENT

Axona® is dosed as a 40g packet mixed into 8 oz of liquid (Ensure) for 45 days

Interventions

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caprylidene

Axona® is dosed as a 40g packet mixed into 8 oz of liquid (Ensure) for 45 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Axona®, AC-1202

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Joshua Grill, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR