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Trial record 5 of 6 for:    AD02 Alzheimer's

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
  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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT01357629     History of Changes
Other Study ID Numbers: AFF004E
First Submitted: March 21, 2011
First Posted: May 23, 2011
Last Update Posted: December 11, 2013
Last Verified: December 2013

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
Neurocognitive Disorders
Mental Disorders