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

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01122329

Acronym

Enrollment

Registered

2010-05-13

Start date

2010-10-31

Completion date

2015-01-31

Last updated

2015-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

dementia

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.

Interventions

DIETARY_SUPPLEMENTcaprylidene

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

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Regional cerebral blood flow (rCBF)	At baseline

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026