- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01538212
Retrospective Cohort Study Of The Efficacy Of Axona® (Medium Chain Triglycerides) In Patients With Alzheimer's Disease (ACT)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months post the start date of Axona
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes from baseline in patient's living situation
Time Frame: 6 months post the start date of Axona
|
6 months post the start date of Axona
|
Changes from baseline in patient's medications for the treatment of AD
Time Frame: 6 months post the start date of Axona
|
6 months post the start date of Axona
|
Changes from baseline in patient's medications for psychiatric conditions related to AD
Time Frame: 6 months post the start date of Axona
|
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
Time Frame: 6 months post the start date of Axona
|
6 months post the start date of Axona
|
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
|
6 months post the start date of Axona
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Samuel T Henderson, PhD, Cerecin
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AX-11-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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