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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01538212
First Posted: February 24, 2012
Last Update Posted: April 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Accera, Inc.
  Purpose
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.

Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Cohort Study Of The Efficacy Of Axona® (Medium Chain Triglycerides) In Patients With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Accera, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Changes from baseline in patient's living situation [ Time Frame: 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 ]
  • Changes from baseline in patient's medications for psychiatric conditions related to AD [ Time Frame: 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 ]
  • 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 ]

Enrollment: 55
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538212


Sponsors and Collaborators
Accera, Inc.
Investigators
Study Director: Samuel T Henderson, PhD Accera, Inc.
  More Information

Responsible Party: Accera, Inc.
ClinicalTrials.gov Identifier: NCT01538212     History of Changes
Other Study ID Numbers: AX-11-009
First Submitted: February 20, 2012
First Posted: February 24, 2012
Last Update Posted: April 18, 2016
Last Verified: April 2016

Keywords provided by Accera, Inc.:
Alzheimer's disease
retrospective
Axona

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders


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