Back to resultsSafety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02
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
Eligibility 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
Sites / Locations
- Ordination Schmitz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AFFITOPE AD02
Arm Description
Outcomes
Primary Outcome Measures
Safety and Tolerability
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01093664
Brief Title
Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Affiris AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AFFITOPE AD02
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
AFFITOPE AD02
Intervention Description
s.c. injection
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
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)
Time Frame
July 2010
Secondary Outcome Measure Information:
Title
Immunological and clinical activity
Description
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
Time Frame
July 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margot Schmitz, Univ. Doz.
Organizational Affiliation
Ordination Schmitz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ordination Schmitz
City
Vienna
ZIP/Postal Code
1010
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02
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