Tolerability and Safety of Subcutaneous Administration of AFFITOPE AD02 in Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
AFFITOPE AD02
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer, Morbus Alzheimer, Alzheimer Vaccine, Vaccine, AD, Aβ immunotherapy
Eligibility Criteria
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.
Sites / Locations
- Ordination Univ. Doz. Dr. Margot Schmitz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
AFFITOPE AD02 without adjuvant
AFFITOPE AD02 with adjuvant
Outcomes
Primary Outcome Measures
Tolerability
Secondary Outcome Measures
Immunological and clinical efficacy (evaluated in explorative manner)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00633841
Brief Title
Tolerability and Safety of Subcutaneous Administration of AFFITOPE AD02 in Mild to Moderate Alzheimer's Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Affiris AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer, Morbus Alzheimer, Alzheimer Vaccine, Vaccine, AD, Aβ immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
AFFITOPE AD02 without adjuvant
Arm Title
2
Arm Type
Active Comparator
Arm Description
AFFITOPE AD02 with adjuvant
Intervention Type
Biological
Intervention Name(s)
AFFITOPE AD02
Intervention Description
4 subcutaneous injections of IP in 4-week intervals
Primary Outcome Measure Information:
Title
Tolerability
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Immunological and clinical efficacy (evaluated in explorative manner)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margot Schmitz, Univ. Doz. Dr.
Organizational Affiliation
Ordination Univ. Doz. Dr. Margot Schmitz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ordination Univ. Doz. Dr. Margot Schmitz
City
Vienna
ZIP/Postal Code
A-1010
Country
Austria
12. IPD Sharing Statement
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Tolerability and Safety of Subcutaneous Administration of AFFITOPE AD02 in Mild to Moderate Alzheimer's Disease
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