Home > Therapeutic vaccines > Morbus Alzheimer > AFFiRiS vaccination programs
Alzheimer is the current lead indication of AFFiRiS. Two product candidates, AFFITOPE® AD01 und AD02, have successfully completed clinical phase I studies. Based on interim analyses of the secondary endpoints AFFiRiS decided to focus first on AFFITOPE® AD02 and started a phase II study on its clinical efficacy in autumn 2010. This multi-center, European project recruits 420 patients with early Alzheimer’s disease, who will be vaccinated repeatedly. The clinical activity of AFFITOPE® AD02 will be assessed on efficacy parameters suggested by the regulatory authority over a period of 12 months. The range of the AFFiRiS Alzheimer vaccine candidates has been extended by AD03. This opens the target spectrum towards the β-amyloid forms that are truncated and/or modified at their amino terminus. Recent scientific studies show that the latter occur early in AD development and that they are particularly toxic.
| Active substance target | N-terminus of β-amyloid (unmodified) |
| Study objective | Assessment of clinical activity of AFFITOPE® AD02 with regard to disease modification |
| Study population | - Patients with early Alzheimer’s disease (MMSE≥20 amongst others) - Age between 50 and 80 years - Availability of a partner/caregiver |
| Study design | Comparison of different doses/formulations of AD02 in a randomized, parallel group study versus Placebo |
| Study durations | 12 months/patient |
| Number of visits | 8 |
| Measured variables | Different memory tests, immune response, safety/tolerability |
| Travel costs | covered by the sponsor |
| Contact: | various centers in Europe registration via www.clinical-trials-vienna.info |
| Active substance target | Truncated and/or pyroglutamate modified N-terminus of β-amyloid |
| Study objective | Assessment of safety/tolerability of AFFITOPE® AD03, explorative assessment of immunological- and clinical efficacy |
| Study population | - Patients with mild to moderate Alzheimer’s disease (MMSE 16-26 amongst others) - Age between 50 and 80 years - Availability of a partner/caregiver |
| Study design | Comparison of two AD03 formulations (+/- adjuvant) in a randomized, parallel group study |
| Study durations | 20 weeks/patient |
| Number of visits | 8 |
| Measured variables | safety/tolerability, different memory tests, immune response |
| Travel costs | covered by the sponsor |
| Contact: | Department for Psychiatry and Psychotherapy, Medical University of Vienna Chairman: o. Univ.Prof. DDr. hc. Dr. Siegfried Kasper Study-biolpsy@meduniwien.ac.at |
For further information on the AFFiRiS clinical studies, please refer to http://clinicaltrials.gov.
