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

Alzheimer Disease Clinical Trial

— AD  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122329
• Other study ID #: GG-AC-1202
• Status: Completed
• Phase: Phase 4
• First received: May 11, 2010
• Last updated: March 19, 2015
• Start date: October 2010
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Dietary Supplement:
• caprylidene
Axona® is dosed as a 40g packet mixed into 8 oz of liquid (Ensure) for 45 days
• Placebo

Locations

Country	Name	City	State
United States	200 Medical Plaza, UCLA Medical Center	Los Angeles	California
United States	Center for Neurotherapeutics at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	John Douglas French Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional cerebral blood flow (rCBF)		At baseline	No
Primary	Regional cerebral blood flow (rCBF)		90 minutes after initation of treatment with Axona®	No
Primary	Regional cerebral blood flow (rCBF)		45 days after initation of treatment with Axona®	No
Secondary	Examine differences between ApoE e4 carriers and noncarriers in changes on rCBF and cognition		At baseline	No
Secondary	To examine the effect of AC-1202 on cognition		At baseline	No
Secondary	Examine differences between ApoE e4 carriers and noncarriers in changes on rCBF and cognition		At 90 minutes after initiation of treatment with Axona®	No
Secondary	Examine differences between ApoE e4 carriers and noncarriers in changes on rCBF and cognition		45 days after initiation of treatment with Axona®	No
Secondary	To examine the effect of AC-1202 on cognition		At 90 minutes after initiation of treatment with Axona®	No
Secondary	To examine the effect of AC-1202 on cognition		45 days after initiation of treatment with Axona®	No