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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01093664
First Posted: March 26, 2010
Last Update Posted: October 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Affiris AG
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    • 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 ]

    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093664


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

Responsible Party: Achim Schneeberger, MD, AFFiRiS AG
ClinicalTrials.gov Identifier: NCT01093664     History of Changes
Other Study ID Numbers: AFF004A
First Submitted: September 2, 2009
First Posted: March 26, 2010
Last Update Posted: October 19, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Vaccines
Immunologic Factors
Physiological Effects of Drugs