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Long-term Safety and Tolerability of AFFITOPE AD02

This study has been completed.
Sponsor:
Information provided by:
Affiris AG
ClinicalTrials.gov Identifier:
NCT00711321
First received: July 4, 2008
Last updated: May 26, 2010
Last verified: May 2010
History of Changes
  Purpose

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


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 AD02 Applied During AFFiRiS 002

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Long-term tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 23
Study Start Date: November 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
2
AFFITOPE AD02 with adjuvant
1
AFFITOPE AD02 without 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711321

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

No publications provided

Responsible Party: Affiris AG, ---
ClinicalTrials.gov Identifier: NCT00711321     History of Changes
Other Study ID Numbers: Affiris 004, EudraCT 2008-002764-33
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
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013