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Long-term Safety and Tolerability of AFFITOPE AD02

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.
ClinicalTrials.gov Identifier: NCT00711321
Recruitment Status : Completed
First Posted : July 8, 2008
Last Update Posted : May 27, 2010
Sponsor:
Information provided by:
Affiris AG

Brief Summary:
The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002

Condition or disease
Alzheimer's Disease

Study Type : Observational
Actual Enrollment : 23 participants
Time Perspective: Prospective
Official Title: Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD02 Applied During AFFiRiS 002
Study Start Date : November 2008
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
2
AFFITOPE AD02 with adjuvant
1
AFFITOPE AD02 without adjuvant



Primary Outcome Measures :
  1. Long-term tolerability [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Clinical and immunological efficacy (evaluated in an explorative manner only) [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects having participated in AFFiRiS 002
Criteria

Inclusion Criteria:

  • Written informed consent signed and dated by patient and caregiver
  • Patients having participated in AFF002 and having received at least 1 vaccination with AFFITOPE AD02
  • Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits

Exclusion Criteria:

  • Patients having received no vaccination with AFFITOPE AD02
  • History of questionable compliance to visit schedule, patients not expected to finish the clinical trial

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): NCT00711321


Locations
Austria
Ordination Schmitz
Vienna, Austria, 1010
Sponsors and Collaborators
Affiris AG
Investigators
Principal Investigator: Margot Schmitz, MD Univ. D. Ordination Schmitz

Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT00711321     History of Changes
Other Study ID Numbers: Affiris 004
EudraCT 2008-002764-33
First Posted: July 8, 2008    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: May 2010

Keywords provided by Affiris AG:
Alzheimer
Morbus Alzheimer
Vaccine
Alzheimer Vaccine
A-beta immunotherapy

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