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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Alzheimer's Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in patient's living situation |  | 6 months post the start date of Axona | 
| Changes from baseline in patient's medications for the treatment of AD |  | 6 months post the start date of Axona | 
| Changes from baseline in patient's medications for psychiatric conditions related to AD |  | 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 |  | 6 months post the start date of Axona | 
| Adverse events assessed by physician's as being possibly associated with the use of Axona |  | 6 months post the start date of Axona | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, retrospective, Axona