Retrospective Cohort Study Of The Efficacy Of Axona® (Medium Chain Triglycerides) In Patients With Alzheimer's Disease (ACT)

April 15, 2016 updated by: Cerecin
This evaluation of the efficacy and safety of AXONA will be a chart review carried out at 16 practices in which AXONA has been prescribed for the treatment of patients with mild-to-moderate AD. Efficacy of AXONA will be assessed by comparison of patient status before and after initiation of treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

The primary objective is to assess the efficacy of AXONA (medium chain triglycerides [MCTs]) when used alone or in combination with other agents in patients with mild-to-moderate Alzheimer's disease (AD) in routine clinical practice.

Study Type

Observational

Enrollment (Actual)

55

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of patients with a diagnosis of mild-to-moderate AD who have been treated with AXONA for ≥ 6 months and whose medical record includes an evaluation within 3 months prior to initiation of treatment and at least one evaluation while receiving AXONA.

Potential for intentional inclusion in the study will be determined on the basis of prescribing data and physicians will be contacted. For Neurology and Psychiatry practices agreeing to participate, all charts meeting the above criteria and for which patients/caregivers give consent will be included in the analysis.

Description

Patient Inclusion Criteria:

  • Male or female outpatients aged ≥ 50 years with a diagnosis of probable AD of mild-to-moderate severity
  • MMSE score between 14 and 24 inclusive at the initiation of AXONA treatment (if available)
  • Has received Axona for a duration of ≥ 6 months

Caregiver Inclusion Criteria (if applicable):

  • Must be at least 21 years of age, has been the primary caregiver since prior to the initiation of Axona, provides at least 4 hours of supervision or direct assistance per day for the patient and is able to perform assessments.

Patient Exclusion Criteria:

  • MMSE score < 14 at the time when AXONA treatment was initiated
  • Presence of co-morbid disease known to adversely impact cognitive function (e.g., Parkinson's disease, history of cerebral infarcts, dementia with Lewy bodies)
  • Vascular dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physician's Overall Assessment of Patient Status at the beginning of Axona treatment and the most recent assessment
Time Frame: 6 months post the start date of Axona
6 months post the start date of Axona

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in patient's living situation
Time Frame: 6 months post the start date of Axona
6 months post the start date of Axona
Changes from baseline in patient's medications for the treatment of AD
Time Frame: 6 months post the start date of Axona
6 months post the start date of Axona
Changes from baseline in patient's medications for psychiatric conditions related to AD
Time Frame: 6 months post the start date of Axona
6 months post the start date of Axona
Changes from baseline in patient's memory and ability to carry out instrumental activities of daily living as assessed by caregivers
Time Frame: 6 months post the start date of Axona
6 months post the start date of Axona
Adverse events assessed by physician's as being possibly associated with the use of Axona
Time Frame: 6 months post the start date of Axona
6 months post the start date of Axona

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Samuel T Henderson, PhD, Cerecin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

February 20, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (ESTIMATE)

February 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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