Trial record 3 of 6 for:    AD02 Alzheimer's

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

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. Identifier: NCT01093664
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : October 19, 2010
Information provided by:
Affiris AG

September 2, 2009
March 26, 2010
October 19, 2010
October 2009
July 2010   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01093664 on Archive Site
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
Same as current
Not Provided
Not Provided
Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02
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
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.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alzheimer's Disease
Biological: AFFITOPE AD02
s.c. injection
Experimental: AFFITOPE AD02
Intervention: Biological: AFFITOPE AD02
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Achim Schneeberger, MD, AFFiRiS AG
Affiris AG
Not Provided
Principal Investigator: Margot Schmitz, Univ. Doz. Ordination Schmitz
Affiris AG
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP