Observational Follow-up Extension Study of AFF002 and AFF004A in Patients With Alzheimer's Disease

This study has been terminated.
(The Study could not be done for every potential participant as planned in the protocol for organizational reasons.)
Sponsor:
Information provided by (Responsible Party):
Affiris AG
ClinicalTrials.gov Identifier:
NCT01357629
First received: March 21, 2011
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

This study examines the long term Safety Follow-up of first patients vaccinated with AD02.


Condition
Alzheimer´s Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Follow-up Extension Study to Evaluate Long-term Safety and Tolerability of Immunizations With AFFITOPE AD02 Applied During AFFiRiS002 and AFF004A in Patients With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Safety [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    collection and evaluation of AEs, SAEs


Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 11
Study Start Date: July 2011
Study Completion Date: November 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Patients who have received AD02 during AFF002 and AFF004A will be observed.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with Alzheimer´s Disease

Criteria

Inclusion Criteria:

  • participation in AFF002 and AFF004A

Exclusion Criteria:

  • no vaccination with AD02
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357629

Locations
Austria
Studienzentrum der PROSENEX Ambulatoriumsbetriebs GmbH
Vienna, Austria, 1080
Univ. Klinik für Psychiatire und Psychotherapie
Wien, Austria, 1090
Sponsors and Collaborators
Affiris AG
Investigators
Study Director: Achim Schneeberger, MD Sponsor GmbH
Principal Investigator: Siegfried Kasper, MD Medical University Vienna
  More Information

No publications provided

Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT01357629     History of Changes
Other Study ID Numbers: AFF004E
Study First Received: March 21, 2011
Last Updated: December 10, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Affiris AG:
Vaccination follow-up

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 April 15, 2014