Long-term Safety and Tolerability of AFFITOPE AD01

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00711139
Recruitment Status : Completed
First Posted : July 8, 2008
Last Update Posted : May 27, 2010
Information provided by:
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

Condition or disease
Alzheimer's Disease

Study Type : Observational
Actual Enrollment : 22 participants
Time Perspective: Prospective
Official Title: Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD01 Applied During AFFiRiS 001
Study Start Date : June 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

AFFITOPE AD01 + Adjuvant

Primary Outcome Measures :
  1. Tolerability [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Immunological and clinical efficacy (evaluated in an explorative manner only) [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects having participated in AFFiRiS 001, as AFFiRiS 003 is a follow-up trial.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00711139

Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Affiris AG
Principal Investigator: Markus Mueller, Univ. Prof. Medical University of Vienna

Responsible Party: Affiris AG Identifier: NCT00711139     History of Changes
Other Study ID Numbers: Affiris 003
EudraCT 2008-001455-22
First Posted: July 8, 2008    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: December 2009

Keywords provided by Affiris AG:
Morbus Alzheimer
Alzheimer Vaccine
A-beta immunotherapy

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders