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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:
ClinicalTrials.gov Identifier:
NCT01357629
First Posted: May 23, 2011
Last Update Posted: December 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Affiris AG
March 21, 2011
May 23, 2011
December 11, 2013
July 2011
April 2013   (Final data collection date for primary outcome measure)
Safety [ Time Frame: up to 2 years ]
collection and evaluation of AEs, SAEs
Safety [ Time Frame: June 2010- June 2012 ]
collection and evaluation of AEs, SAEs
Complete list of historical versions of study NCT01357629 on ClinicalTrials.gov Archive Site
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Observational Follow-up Extension Study of AFF002 and AFF004A in Patients With Alzheimer's Disease
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
This study examines the long term Safety Follow-up of first patients vaccinated with AD02.
Patients who have received AD02 during AFF002 and AFF004A will be observed.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:
Serum
Probability Sample
Patients with Alzheimer´s Disease
Alzheimer´s Disease
Not Provided
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
November 2013
April 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • participation in AFF002 and AFF004A

Exclusion Criteria:

  • no vaccination with AD02
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT01357629
AFF004E
No
Not Provided
Not Provided
Affiris AG
Affiris AG
Not Provided
Study Director: Achim Schneeberger, MD Sponsor GmbH
Principal Investigator: Siegfried Kasper, MD Medical University Vienna
Affiris AG
December 2013