NCT01122329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4 alzheimer-disease

Timeline
Completed

Started Oct 2010

Typical duration for phase_4 alzheimer-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 23, 2015

Status Verified

March 1, 2015

Enrollment Period

4.3 years

First QC Date

May 11, 2010

Last Update Submit

March 19, 2015

Conditions

Alzheimer Disease

Keywords

dementia

Outcome Measures

Primary Outcomes (3)

  • Regional cerebral blood flow (rCBF)

    At baseline

  • Regional cerebral blood flow (rCBF)

    90 minutes after initation of treatment with Axona®

  • Regional cerebral blood flow (rCBF)

    45 days after initation of treatment with Axona®

Secondary Outcomes (6)

  • 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

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

    At 90 minutes after initiation of treatment with Axona®

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

    45 days after initiation of treatment with Axona®

  • To examine the effect of AC-1202 on cognition

    At 90 minutes after initiation of treatment with Axona®

  • +1 more secondary outcomes

Study Arms (2)

inactive food packet

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Axona®

ACTIVE COMPARATOR
Dietary Supplement: caprylidene

Interventions

caprylideneDIETARY_SUPPLEMENT

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

Also known as: Axona®, AC-1202
Axona®
PlaceboDIETARY_SUPPLEMENT
inactive food packet

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

200 Medical Plaza, UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Center for Neurotherapeutics at UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

caprylideneAC-1202

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Joshua Grill, PhD

    Mary S. Easton Center for Alzheimer's Disease Research at UCLA

    PRINCIPAL INVESTIGATOR

  • John Ringman, MD

    Mary S. Easton Center for Alzheimer's Disease Research at UCLA

    STUDY CHAIR

  • Maryam Beigi, MD

    Mary S. Easton Center for Alzheimer's Disease Research at UCLA

    STUDY CHAIR

  • Ellen Woo, PhD

    Mary S. Easton Center for Alzheimer's Disease Research at UCLA

    STUDY CHAIR

  • Dan Silverman, MD, PhD

    UCLA Department of Molecular and Medical Pharmacology

    STUDY CHAIR

  • Cathy Lee, PhD

    Mary S. Easton Center for Alzheimer's Disease Research at UCLA

    STUDY CHAIR

  • Jeffrey Cummings, MD

    Mary S. Easton Center for Alzheimer's Disease Research at UCLA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 11, 2010

First Posted

May 13, 2010

Study Start

October 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 23, 2015

Record last verified: 2015-03

Locations

US(2)