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Completed

NCT Number: NCT01122329

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

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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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

200 Medical Plaza, UCLA Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

caprylidene

Dietary Supplement

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

Other names: Axona®, AC-1202

Placebo

Dietary Supplement

Primary outcomes

  1. Regional cerebral blood flow (rCBF)

    Time frame: At baseline

  2. Regional cerebral blood flow (rCBF)

    Time frame: 90 minutes after initation of treatment with Axona®

  3. Regional cerebral blood flow (rCBF)

    Time frame: 45 days after initation of treatment with Axona®

Secondary outcomes

  1. Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition

    Time frame: At baseline

  2. To examine the effect of AC-1202 on cognition

    Time frame: At baseline

  3. 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®

  4. Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition

    Time frame: 45 days after initiation of treatment with Axona®

  5. To examine the effect of AC-1202 on cognition

    Time frame: At 90 minutes after initiation of treatment with Axona®

  6. To examine the effect of AC-1202 on cognition

    Time frame: 45 days after initiation of treatment with Axona®

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • John Douglas French Foundation

Registry information

Official study 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)

Acronym: AD

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 13, 2010
Registry last updated
Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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