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

NCT01538212 | Completed

• 1 other identifier: AX-11-009
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; retrospective; Axona

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerecin: lead

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Samuel T Henderson, PhD

  Cerecin

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: February 24, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 18, 2016

Record last verified: 2016-04