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

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. Identifier: NCT01357629
Recruitment Status : Terminated (The Study could not be done for every potential participant as planned in the protocol for organizational reasons.)
First Posted : May 23, 2011
Last Update Posted : December 11, 2013
Information provided by (Responsible Party):
Affiris AG

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

Condition or disease
Alzheimer´s Disease

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

Study Type : Observational
Actual Enrollment : 11 participants
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
Study Start Date : July 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Safety [ Time Frame: up to 2 years ]
    collection and evaluation of AEs, SAEs

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Alzheimer´s Disease

Inclusion Criteria:

  • participation in AFF002 and AFF004A

Exclusion Criteria:

  • no vaccination with AD02

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01357629

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

Responsible Party: Affiris AG Identifier: NCT01357629     History of Changes
Other Study ID Numbers: AFF004E
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by Affiris AG:
Vaccination follow-up

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders