Long-term Safety and Tolerability of AFFITOPE AD01

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT00711139
• Lead Sponsor: Affiris AG

Brief Summary

The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE AD01 applied during AFFiRiS 001

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-04
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-08
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2009-12
• Last Update Submitted: 2010-05-26
• Last Update Posted: 2010-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tolerability	1 year

Secondary Outcome Measures

Name	Time	Method
Immunological and clinical efficacy (evaluated in an explorative manner only)	1 year

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria