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Long-term Safety and Tolerability of AFFITOPE AD01

This study has been completed.
Information provided by:
Affiris AG Identifier:
First received: July 4, 2008
Last updated: May 26, 2010
Last verified: December 2009
The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE AD01 applied during AFFiRiS 001

Alzheimer's Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Affiris AG:

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

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

Biospecimen Retention:   Samples Without DNA

Enrollment: 22
Study Start Date: June 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
AFFITOPE AD01 + Adjuvant


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Affiris AG Identifier: NCT00711139     History of Changes
Other Study ID Numbers: Affiris 003
EudraCT 2008-001455-22
Study First Received: July 4, 2008
Last Updated: May 26, 2010

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 processed this record on August 18, 2017