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
  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:


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
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: 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 August 20, 2014