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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:
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

March 21, 2011
December 10, 2013
July 2011
April 2013   (final data collection date for primary outcome measure)
Safety [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
collection and evaluation of AEs, SAEs
Safety [ Time Frame: June 2010- June 2012 ] [ Designated as safety issue: Yes ]
collection and evaluation of AEs, SAEs
Complete list of historical versions of study NCT01357629 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01357629
AFF004E
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP