Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT01538212
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01538212
Study Brief:
Protocol Section:
NCT01538212