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Long-term Safety and Tolerability of AFFITOPE AD02

This study has been completed.
Information provided by:
Affiris AG Identifier:
First received: July 4, 2008
Last updated: May 26, 2010
Last verified: May 2010
The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002

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 AD02 Applied During AFFiRiS 002

Resource links provided by NLM:

Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Long-term tolerability [ Time Frame: 1 year ]

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

Biospecimen Retention:   Samples Without DNA

Enrollment: 23
Study Start Date: November 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
AFFITOPE AD02 with adjuvant
AFFITOPE AD02 without 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 002

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
  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: NCT00711321

Ordination Schmitz
Vienna, Austria, 1010
Sponsors and Collaborators
Affiris AG
Principal Investigator: Margot Schmitz, MD Univ. D. Ordination Schmitz
  More Information

Responsible Party: Affiris AG Identifier: NCT00711321     History of Changes
Other Study ID Numbers: Affiris 004
EudraCT 2008-002764-33
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