NCT00711139CompletedNot Applicable
Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD01 Applied During AFFiRiS 001
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Affiris AG
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Tolerability
Study Overview
Brief Summary
The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE AD01 applied during AFFiRiS 001
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent signed and dated by the patient or the patient's legal representative and the caregiver
- •Patients having participated in AFFiRiS 001 and received at least 1 vaccination with AFFITOPE AD01
- •Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits.
Exclusion Criteria
- •Patients having received no vaccination with AFFITOPE AD01
- •Contraindication for MRI imaging
- •History of questionable compliance to visit schedule, patients not expected to complete the clinical trial
Outcomes
Primary Outcomes
Tolerability
Time Frame: 1 year
Secondary Outcomes
- Immunological and clinical efficacy (evaluated in an explorative manner only)(1 year)
Investigators
Study Sites (1)
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