Clinical trial NCT01538212: Retrospective Cohort Study Of The Efficacy Of Axona® (Medium Chain Triglycerides) In Patients With Alzheimer's Disease
Official title: Retrospective Cohort Study Of The Efficacy Of Axona® (Medium Chain Triglycerides) In Patients With Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
retrospective
Axona
Lead sponsor: Cerecin
Sponsor class: INDUSTRY
First posted: 2012-02-24
Enrollment: 55
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

Brief 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.

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 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

Primary outcomes:
measure: Physician's Overall Assessment of Patient Status at the beginning of Axona treatment and the most recent assessment
timeFrame: 6 months post the start date of Axona
Secondary outcomes:
measure: Changes from baseline in patient's living situation
timeFrame: 6 months post the start date of Axona
measure: Changes from baseline in patient's medications for the treatment of AD
timeFrame: 6 months post the start date of Axona
measure: Changes from baseline in patient's medications for psychiatric conditions related to AD
timeFrame: 6 months post the start date of Axona
measure: Changes from baseline in patient's memory and ability to carry out instrumental activities of daily living as assessed by caregivers
timeFrame: 6 months post the start date of Axona
measure: Adverse events assessed by physician's as being possibly associated with the use of Axona
timeFrame: 6 months post the start date of Axona
Other outcomes:
Locations:
Study officials:
affiliation: Cerecin
name: Samuel T Henderson, PhD
role: STUDY_DIRECTOR
References: