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Retrospective Cohort Study Of...

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

Last Updated: 2016-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-10-31

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.

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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.

Conditions

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Alzheimer's Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

* 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.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers