Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02

This study has been completed.
Sponsor:
Information provided by:
Affiris AG
ClinicalTrials.gov Identifier:
NCT01093664
First received: September 2, 2009
Last updated: October 18, 2010
Last verified: October 2010
  Purpose

This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who have received the vaccine within the clinical study AFF002.


Condition Intervention Phase
Alzheimer's Disease
Biological: AFFITOPE AD02
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IB Follow-up Study to Assess a Boost Immunization With AFFITOPE AD02 With Regard to Safety/Tolerability, Immunological and Clinical Activity in Alzheimer Patients Who Have Received the Vaccine Within the Clinical Study AFF002

Resource links provided by NLM:


Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: July 2010 ] [ Designated as safety issue: Yes ]
    • Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal
    • Adverse events (AEs)
    • Serious adverse events (SAEs)
    • Physical and neurological examination
    • Concomitant medication
    • Vital signs (blood pressure, heart rate, respiratory rate, body temperature)
    • Body mass (weight and height)
    • MRI of brain
    • ECG
    • Laboratory assessment (haematology, biochemistry, coagulation, serology and urinalysis)


Secondary Outcome Measures:
  • Immunological and clinical activity [ Time Frame: July 2010 ] [ Designated as safety issue: No ]

    Immunological parameters:

    - Assessment of the immune response triggered by the vaccine (titre of IgG antibodies specific for the immunizing peptide, N-terminal part of Aβ, (irrelevant peptide serves as specificity control), Aβ itself and KLH as assessed by ELlSA as well as the results of the biacore affinity measurements towards the immunizing peptide and Aβ)

    Clinical efficacy variables:

    • Cognitive and functional tests, behavioural scales
    • Measurement of quality of life in patients with Alzheimer's disease
    • Investigator's global evaluation scale


Enrollment: 20
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AFFITOPE AD02 Biological: AFFITOPE AD02
s.c. injection

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in AFF002 and AFF004

Exclusion Criteria:

  • Presence or history of allergy to components of the vaccine, if considered relevant by the investigator
  • Contraindication for MRI imaging
  • History and/or presence of autoimmune disease, if considered relevant by the investigator
  • Active infectious disease (e.g., Hepatitis B, C)
  • Presence and/or history of Immunodeficiency (e.g., HIV)
  • Significant systemic illness
  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: NCT01093664

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

No publications provided

Responsible Party: Achim Schneeberger, MD, AFFiRiS AG
ClinicalTrials.gov Identifier: NCT01093664     History of Changes
Other Study ID Numbers: AFF004A
Study First Received: September 2, 2009
Last Updated: October 18, 2010
Health Authority: Austria: Federal Office for Safety in Health Care

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 July 31, 2014