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
  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:


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
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 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 September 16, 2014