s.c. injection

• 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)

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