Long-term Safety and Tolerability of AFFITOPE AD01

Alzheimer's Disease Clinical Trial

Official title:

Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD01 Applied During AFFiRiS 001

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711139
• Other study ID #: Affiris 003
• Secondary ID: EudraCT 2008-001
• Status: Completed
• Phase: N/A
• First received: July 4, 2008
• Last updated: May 26, 2010
• Start date: June 2008
• Est. completion date: November 2009

Study information

• Verified date: December 2009
• Source: Affiris AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Affiris AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability		1 year	Yes
Secondary	Immunological and clinical efficacy (evaluated in an explorative manner only)		1 year	No