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AD01 Follow up Extension Visit

This study has been completed.
Sponsor:
Information provided by:
Affiris AG
ClinicalTrials.gov Identifier:
NCT01225809
First received: October 18, 2010
Last updated: January 25, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Long term tolerability and safety of AFFITOPE AD01 [ Time Frame: One year. ] [ Designated as safety issue: Yes ]
    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)
Groups/Cohorts
AD01with or without adjuvant
Patients who have received at least one immunization of AD01 with or without adjuvant during AFF001

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225809

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

No publications provided

Responsible Party: Achim Schneeberger; CMO, AFFiRiS AG
ClinicalTrials.gov Identifier: NCT01225809     History of Changes
Other Study ID Numbers: AFF003E
Study First Received: October 18, 2010
Last Updated: January 25, 2011
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Affiris AG:
AD01 follow-up extension

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013