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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

caprylidene

Placebo

About this trial

This is an interventional basic science trial for Alzheimer Disease focused on measuring dementia

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

200 Medical Plaza, UCLA Medical Center
Center for Neurotherapeutics at UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

inactive food packet

Axona®

Arm Description

Outcomes

Primary Outcome Measures

Regional cerebral blood flow (rCBF)

Secondary Outcome Measures

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

To examine the effect of AC-1202 on cognition

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

To examine the effect of AC-1202 on cognition

Full Information

NCT ID

NCT01122329

First Posted

May 11, 2010

Last Updated

March 19, 2015

Sponsor

University of California, Los Angeles

Collaborators

John Douglas French Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01122329

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

John Douglas French Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

dementia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

inactive food packet

Arm Type

Placebo Comparator

Arm Title

Axona®

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

caprylidene

Other Intervention Name(s)

Axona®, AC-1202

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Regional cerebral blood flow (rCBF)

Time Frame

At baseline

Title

Regional cerebral blood flow (rCBF)

Time Frame

90 minutes after initation of treatment with Axona®

Title

Regional cerebral blood flow (rCBF)

Time Frame

45 days after initation of treatment with Axona®

Secondary Outcome Measure Information:

Title

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

Time Frame

At baseline

Title

To examine the effect of AC-1202 on cognition

Time Frame

At baseline

Title

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®

Title

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

Time Frame

45 days after initiation of treatment with Axona®

Title

To examine the effect of AC-1202 on cognition

Time Frame

At 90 minutes after initiation of treatment with Axona®

Title

To examine the effect of AC-1202 on cognition

Time Frame

45 days after initiation of treatment with Axona®

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: