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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Accera, Inc.
ClinicalTrials.gov Identifier:
NCT01538212
First received: February 20, 2012
Last updated: February 23, 2012
Last verified: February 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes from baseline in patient's living situation [ Time Frame: 6 months post the start date of Axona ] [ Designated as safety issue: No ]
  • Changes from baseline in patient's medications for the treatment of AD [ Time Frame: 6 months post the start date of Axona ] [ Designated as safety issue: No ]
  • Changes from baseline in patient's medications for psychiatric conditions related to AD [ Time Frame: 6 months post the start date of Axona ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538212

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

No publications provided

Responsible Party: Accera, Inc.
ClinicalTrials.gov Identifier: NCT01538212     History of Changes
Other Study ID Numbers: AX-11-009
Study First Received: February 20, 2012
Last Updated: February 23, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 27, 2014