This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
194
Composite Measures of Primary Safety and Tolerability Endpoints
* Withdrawal criteria * Number of Adverse events (AEs) * Number of any serious adverse events (SAE) * Alzheimer's Disease Assessment Scale - Cognition (ADAScog) * Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL)
Time frame: 19 months
Composite Measures of Secondary Efficacy Endpoints
* Clinical Dementia Rating Sum of Boxes (CDR-sb) * Free and Cued Selective Reminding Test (FCSRT) * Standard neuropsychological test battery (CogState) * Mini-Mental State Examination (MMSE) * Investigator's global evaluation scale (IGE) * CDR \[global aspects\] * Neuropsychiatric Inventory (NPI) \[behavior\] * quality of life (QOL) -AD
Time frame: 19 months
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Landeskrankenhaus Hall Gedächtnisambulanz
Hall in Tirol, Austria
LNK Wagner-Jauregg, Dept. of geriatrics
Linz, Austria
Christian Doppler Klinik, Univ. Klinik f. Neurologie
Salzburg, Austria
MUW Klin. Pharmakologie und Klinik für Neurologie
Vienna, Austria
MUW, Klin.Abt.f. Biolog. Psychiatrie
Vienna, Austria
SMZ-Ost, Psychiatric Dep.
Vienna, Austria
Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju
Rijeka, Croatia
Opća bolnica Varaždin, Klinika za Neurologiju
Varaždin, Croatia
"BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju
Zagreb, Croatia
Psihijatrijska Bolnica Vrapče
Zagreb, Croatia
...and 17 more locations