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:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT03668405
Eligibility Criteria:
Main inclusion criteria:
* The patient has completed the 16026A study and has received the last study treatment within 12 months of the screening visit for the present study.
* The patient has an MRI scan done in relation to study 16026A performed within 9 months before first study visit in the extension study.
* The patient has a knowledgeable and reliable caregiver/ study partner who will be available and able to accompany the patient to clinical visits, monitor Immunisation-Related Events after each immunisation, and participate with the patient at phone visits during the study
Main exclusion criteria:
* The patient uses or has recently used (pre-trial time limits specified in Appendix II) disallowed concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications (Appendix II) during the study.
* The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety and tolerability
More inclusion and exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT03668405
Study Brief:
Protocol Section:
NCT03668405