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

Cerecin

Status: Completed

Conditions: Alzheimer's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01538212

AX-11-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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