This study evaluates the safety and efficacy of AADvac1 in the treatment of patients with mild Alzheimer's disease. 60% of participants will receive AADvac1 and 40% of participants will receive placebo.
Alzheimer's disease (AD) is a chronic progressive neurodegenerative disorder of the brain. Over the course of the disease, pathological proteins accumulate in the brain, damaging neurons, thus causing them to lose their connections and die. Currently available treatments are designed to compensate for the neurotransmitter loss caused by the disease without affecting the disease process itself. AADvac1 is designed to raise antibodies against pathological tau protein (the primary constituent of neurofibrillary pathology in AD). These antibodies are expected to prevent tau protein from aggregating, to facilitate the removal of tau protein aggregates and prevent the spreading of pathology, slowing or halting the progress of the disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
208
Safety (all-case treatment-emergent adverse events except local reactions)
The safety and tolerability of AADvac1 in the treatment of patients with mild Alzheimer disease, as assessed by AEs, vital signs, ECG, laboratory measures, MRI of the brain, physical and neurological examination, Columbia Suicide Severity Rating Scale (C-SSRS) and review of the Patient Diary
Time frame: 24 months
Clinical Dementia Rating (CDR) Sum of Boxes
The domain scores of the standard 6-domain CDR assessment will be summed up to obtain a Sum-of-Boxes score of 0-18
Time frame: 24 months
Custom cognitive battery (composite standard score)
A composite standard score will be calculated from the following tests: Cogstate International Shopping List Task (memory) * immediate free recall * delayed free recall * delayed recognition Cogstate One Card Learning Task (memory) Cogstate One Card Back Task (memory) Category Fluency Test (executive function, language) Letter Fluency Test (executive function, language) Digit Symbol Coding (executive functioning, working memory and processing speed)
Time frame: 24 months
Alzheimer's Disease Cooperative Study - Activities of Daily Living questionnaire (version for Mild Cognitive Impairment) (ADCS MCI ADL)
Activities of daily living will be assessed using the informant-based ADCS questionnaire (both the score for the 18-point and the 24-point version will be calculated)
Time frame: 24 months
Immunogenicity
Time frame: 24 months
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Ordination Dr. Bancher
Horn, Lower Austria, Austria
Universitätsklinik für Neurologie
Graz, Styria, Austria
Abteilung Psychiatrie und Psychotherapie, LKH Hall
Hall in Tirol, Tyrol, Austria
Universitätsklinikum Innsbruck
Innsbruck, Tyrol, Austria
Fakultni nemocnice u sv. Anny v Brne, Mezinarodni centrum klinickeho vyzkumu (ICRC), Centrum pro kognitivni poruchy, Neuro 2
Brno, Czechia
Fakultni nemocnice Hradec Kralove, Neurologicka Klinika
Hradec Králové, Czechia
Narodni ustav dusevniho zdravi (NÚDZ), Department of cognitive disorders - AD Center
Klecany, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Fakultni nemocnice v Motole
Prague, Czechia
Neuro Centrum Odenwald
Erbach, Rhineland-Palatinate, Germany
...and 32 more locations