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Long-term Safety and Tolerability of AFFITOPE AD01

This study has been completed.
Sponsor:
Information provided by:
Affiris AG
ClinicalTrials.gov Identifier:
NCT00711139
First received: July 4, 2008
Last updated: May 26, 2010
Last verified: December 2009
History of Changes
  Purpose

The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE AD01 applied during AFFiRiS 001


Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD01 Applied During AFFiRiS 001

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunological and clinical efficacy (evaluated in an explorative manner only) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 22
Study Start Date: June 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
AFFITOPE AD01
2
AFFITOPE AD01 + Adjuvant

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects having participated in AFFiRiS 001, as AFFiRiS 003 is a follow-up trial.

Criteria

Inclusion Criteria:

  • Written informed consent signed and dated by the patient or the patient's legal representative and the caregiver
  • Patients having participated in AFFiRiS 001 and received at least 1 vaccination with AFFITOPE AD01
  • 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 AD01
  • Contraindication for MRI imaging
  • History of questionable compliance to visit schedule, patients not expected to complete the clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711139

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Affiris AG
Investigators
Principal Investigator: Markus Mueller, Univ. Prof. Medical University of Vienna
  More Information

No publications provided

Responsible Party: Affiris AG, ---
ClinicalTrials.gov Identifier: NCT00711139     History of Changes
Other Study ID Numbers: Affiris 003, EudraCT 2008-001455-22
Study First Received: July 4, 2008
Last Updated: May 26, 2010
Health Authority: Austria: Agency for Health and Food Safety

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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013