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
  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:


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
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, see Learn About Clinical Studies.

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 October 19, 2014