Alzheimer's DiseaseACTNCT01538212
Retrospective Cohort Study Of The Efficacy Of Axona® (Medium Chain Triglycerides) In Patients With Alzheimer's Disease
An observational study of Alzheimer's Disease, run by Cerecin.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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
About this study
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, retrospective, Axona
- Medical subject headings
- Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Overall Assessment of Patient Status at the beginning of Axona treatment and the most recent assessment
Measured: 6 months post the start date of Axona
Secondary outcomes (5)
Changes from baseline in patient's living situation
Measured: 6 months post the start date of Axona
Changes from baseline in patient's medications for the treatment of AD
Measured: 6 months post the start date of Axona
Changes from baseline in patient's medications for psychiatric conditions related to AD
Measured: 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
Measured: 6 months post the start date of Axona
Adverse events assessed by physician's as being possibly associated with the use of Axona
Measured: 6 months post the start date of Axona
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerecin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel T Henderson, PhD, Study director, Cerecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538212
- Sponsor's protocol ID
- AX-11-009
- Acronym
- ACT
- Status last verified
- Apr 2016
- First submitted
- 20 Feb 2012
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study Of The Efficacy Of Axona® (Medium Chain Triglycerides) In Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01538212
- Acronym / sponsor ID
- ACT / AX-11-009
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, retrospective, Axona
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Changes from baseline in patient's living situation
Time frame: 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
Changes from baseline in patient's medications for psychiatric conditions related to AD
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel T Henderson, PhD study director
Cerecin
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Cerecin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.