Status:
COMPLETED
Tolerability and Safety of Subcutaneous Administration of AFFITOPE AD02 in Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Affiris AG
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE1
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 th...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00633841
Start Date
February 1 2008
End Date
September 1 2009
Last Update
October 19 2010
Active Locations (1)
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1
Ordination Univ. Doz. Dr. Margot Schmitz
Vienna, Austria, A-1010