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Completed

NCT Number: NCT01538212

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

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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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes from baseline in patient's living situation

    Time frame: 6 months post the start date of Axona

  2. Changes from baseline in patient's medications for the treatment of AD

    Time frame: 6 months post the start date of Axona

  3. Changes from baseline in patient's medications for psychiatric conditions related to AD

    Time frame: 6 months post the start date of Axona

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Cerecin

Industry

Registry information

Acronym: ACT

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 24, 2012
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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