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

University of California, Los Angeles (UCLA)

Status and phase

Completed

Phase 4

Conditions

Alzheimer Disease

Treatments

Dietary Supplement: Placebo

Dietary Supplement: caprylidene

Study type

Interventional

Funder types

Other

Identifiers

NCT01122329

GG-AC-1202

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No 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