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Tolerability and Safety of Subcutaneous Administration of AFFITOPE AD02 in Mild to Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00633841
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : October 19, 2010
Sponsor:
Information provided by:
Affiris AG

Tracking Information
First Submitted Date  ICMJE March 5, 2008
First Posted Date  ICMJE March 12, 2008
Last Update Posted Date October 19, 2010
Study Start Date  ICMJE February 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
Tolerability [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
Immunological and clinical efficacy (evaluated in explorative manner) [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tolerability and Safety of Subcutaneous Administration of AFFITOPE AD02 in Mild to Moderate Alzheimer's Disease
Official Title  ICMJE Randomized, Controlled, Parallel Group, Patient-Blinded, Single-Center Phase I Pilot Study to Assess Tolerability and Safety of Repeated s.c. Administration of a Single-Dose of AFFITOPE AD02 Applied With or Without Adjuvant to Patients With Mild to Moderate Alzheimer's Disease
Brief Summary The purpose of this study is to assess the tolerability and safety of repeated subcutaneous injection of a single dose of AFFITOPE AD02 in patients with mild to moderate Alzheimer's Disease.
Detailed Description

Alzheimer's Disease (AD) is a devastating neurodegenerative disorder for which there is no cure.

Although the etiology of AD is not fully understood, recent research suggests that Aβ is central to the disease process. Consequently, approaches capable of removing Aβ from the brain, such as Aβ immunotherapy, are expected to possess disease-modifying potential. This view is supported by evidence gathered in mouse models of AD and studies involving AD patients.

Based on the view that active Aβ immunotherapy has disease-modifying potential both in animal models of AD and in patients, and on the knowledge gathered on the side-effects of Aβ-based immunotherapy encountered in humans, we designed a new generation of AD vaccines. Rather than using full length Aβ itself, we choose to use mimotopes of the N-terminal end of Aβ as the antigenic component of our vaccine (Mimotopes discovered by Affiris GmbH have been termed AFFITOPES). Mimotopes are peptides that functionally mimic the native antigenic epitope but do not show sequence identity to it. Thus, while being different from the original antigen, mimotopes are recognized by the same antibodies and, vice versa, are capable of inducing antibodies that cross-react with the original antigen itself. A major advantage offered by mimotopes is the lack of tolerance mechanisms that would prevent the induction of an immune response to it (as is the case with self peptides/proteins such as Aβ). To further increase the vaccine's safety profile, the length of the mimotope used was limited to preclude the elicitation of Aβ-specific T cells. Also, the mimotope used has been designed to generate antibodies directed exclusively to Aβ (i.e., they do not recognize parental APP itself). To provide helper epitopes for the generation of an antibody response, the mimotope is coupled to a carrier.

The trial is designed as a patient-blinded, single-center, randomized, controlled, parallel group, phase I clinical study of repeated once every 4 weeks administration by subcutaneous injection of AFFITOPE AD02 alone or adsorbed to aluminium hydroxide in 24 patients with mild to moderate Alzheimer's Disease. In total, each patient will receive 4 immunizations. Patients will be randomized to receive AFFITOPE AD02 alone or adsorbed to alumimium hydroxide. Each treatment group consists of 12 patients. For safety reasons, inclusion of patients will be done in a stepwise manner.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Biological: AFFITOPE AD02
4 subcutaneous injections of IP in 4-week intervals
Study Arms  ICMJE
  • Active Comparator: 1
    AFFITOPE AD02 without adjuvant
    Intervention: Biological: AFFITOPE AD02
  • Active Comparator: 2
    AFFITOPE AD02 with adjuvant
    Intervention: Biological: AFFITOPE AD02
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2008)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

  • Diagnosis of probable Alzheimer's disease based on the NINCDS/ADRDA criteria.
  • Alzheimer's disease of mild to moderate degree (MMSE 16-26)
  • Magnetic Resonance Imaging scan (MRI) of brain consistent with diagnosis of AD.
  • Written informed consent signed and dated by the patient and the caregiver.
  • Age 50-80 years.
  • Availability of a partner/caregiver

Other Inclusion Criteria apply.

Main Exclusion Criteria:

  • Presence or history of allergy to components of the vaccine.
  • Contraindication for MRI imaging.
  • Participation in another clinical trial.
  • Prior and/or current treatment with experimental immunotherapeutics including IVIG or vaccines for AD.
  • Prior and/or current treatment with immunosuppressive drugs
  • History and/or presence of autoimmune disease.

Other Exclusion Criteria apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00633841
Other Study ID Numbers  ICMJE Affiris 002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Affiris GmbH
Study Sponsor  ICMJE Affiris AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Margot Schmitz, Univ. Doz. Dr. Ordination Univ. Doz. Dr. Margot Schmitz
PRS Account Affiris AG
Verification Date October 2010

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