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

Alzheimer's Disease Clinical Trial

— ACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538212
• Other study ID #: AX-11-009
• Status: Completed
• Phase: N/A
• First received: February 20, 2012
• Last updated: April 15, 2016
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: April 2016
• Source: Accera, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Accera, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician's Overall Assessment of Patient Status at the beginning of Axona treatment and the most recent assessment		6 months post the start date of Axona	No
Secondary	Changes from baseline in patient's living situation		6 months post the start date of Axona	No
Secondary	Changes from baseline in patient's medications for the treatment of AD		6 months post the start date of Axona	No
Secondary	Changes from baseline in patient's medications for psychiatric conditions related to AD		6 months post the start date of Axona	No
Secondary	Changes from baseline in patient's memory and ability to carry out instrumental activities of daily living as assessed by caregivers		6 months post the start date of Axona	No
Secondary	Adverse events assessed by physician's as being possibly associated with the use of Axona		6 months post the start date of Axona	Yes