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AD01 Follow up Extension Visit

This study has been completed.
Information provided by:
Affiris AG Identifier:
First received: October 18, 2010
Last updated: January 25, 2011
Last verified: January 2011
Patients who were vaccinated with AFFITOPE AD01 during AFFiRiS001 will undergo a long-term follow-up period to get more information regarding the safety profile of AFFITOPE AD01.

Alzheimer´s Disease

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Observational Follow-up Extension Study-visit to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD01 Applied During AFFiRiS001 in Patients With Alzheimer's Disease

Resource links provided by NLM:

Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Long term tolerability and safety of AFFITOPE AD01 [ Time Frame: One year. ]
    retrospective assessment of safety data

Enrollment: 17
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
AD01with or without adjuvant
Patients who have received at least one immunization of AD01 with or without adjuvant during AFF001


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients having participated in AFFiRiS 001 and AFF003 and having received ≥1 vaccination with AFFITOPE AD01

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 AFF003 and having received ≥1 vaccination with AFFITOPE AD01
  • Availability of a partner/caregiver knowing the patient

Exclusion Criteria:

  • Patients having received no vaccination with AFFITOPE AD01
  • History of questionable compliance to visit schedule
  Contacts and Locations
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Please refer to this study by its identifier: NCT01225809

Univ. Klinik für Neurologie
Wien, Austria, 1090
Sponsors and Collaborators
Affiris AG
Principal Investigator: Peter Dal-Bianco, MD Univ. Klinik für Neurologie
  More Information

Responsible Party: Achim Schneeberger; CMO, AFFiRiS AG Identifier: NCT01225809     History of Changes
Other Study ID Numbers: AFF003E
Study First Received: October 18, 2010
Last Updated: January 25, 2011

Keywords provided by Affiris AG:
AD01 follow-up extension

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 April 25, 2017