Long-term Safety and Tolerability of AFFITOPE AD02

Alzheimer's Disease Clinical Trial

Official title:

Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD02 Applied During AFFiRiS 002

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711321
• Other study ID #: Affiris 004
• Secondary ID: EudraCT 2008-002
• Status: Completed
• Phase: N/A
• First received: July 4, 2008
• Last updated: May 26, 2010
• Start date: November 2008
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• 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 evaluate the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent signed and dated by patient and caregiver

• Patients having participated in AFF002 and having received at least 1 vaccination with AFFITOPE AD02

• 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 AD02

• History of questionable compliance to visit schedule, patients not expected to finish the clinical trial

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
Austria	Ordination Schmitz	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Affiris AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term tolerability		1 year	Yes
Secondary	Clinical and immunological efficacy (evaluated in an explorative manner only)		1 year	No