- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01357629
Observational Follow-up Extension Study of AFF002 and AFF004A in Patients With Alzheimer's Disease
December 10, 2013 updated by: Affiris AG
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.
Study Overview
Status
Terminated
Conditions
Detailed Description
Patients who have received AD02 during AFF002 and AFF004A will be observed.
Study Type
Observational
Enrollment (Actual)
11
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Vienna, Austria, 1080
- Studienzentrum der PROSENEX Ambulatoriumsbetriebs GmbH
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Wien, Austria, 1090
- Univ. Klinik für Psychiatire und Psychotherapie
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with Alzheimer´s Disease
Description
Inclusion Criteria:
- participation in AFF002 and AFF004A
Exclusion Criteria:
- no vaccination with AD02
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: up to 2 years
|
collection and evaluation of AEs, SAEs
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Achim Schneeberger, MD, Sponsor GmbH
- Principal Investigator: Siegfried Kasper, MD, Medical University Vienna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
March 21, 2011
First Submitted That Met QC Criteria
May 20, 2011
First Posted (Estimate)
May 23, 2011
Study Record Updates
Last Update Posted (Estimate)
December 11, 2013
Last Update Submitted That Met QC Criteria
December 10, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFF004E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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