AD01 Follow up Extension Visit

Completed

• Conditions: Alzheimer´s Disease

• Registration Number: NCT01225809
• Lead Sponsor: Affiris AG

Brief Summary

Patients who were vaccinated with AFFITOPE AD01 during AFFiRiS001 will undergo a long-term follow-up period to get more information regarding the safety profile of AFFITOPE AD01.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Primary Completion: 2010-12
• Status Verified: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 AFF003 and having received ≥1 vaccination with AFFITOPE AD01
• Availability of a partner/caregiver knowing the patient

Exclusion Criteria

• Patients having received no vaccination with AFFITOPE AD01
• History of questionable compliance to visit schedule

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long term tolerability and safety of AFFITOPE AD01	One year.	retrospective assessment of safety data

Trial Locations

Locations (1)

Univ. Klinik für Neurologie; 🇦🇹 Wien, Austria