24 Months Safety and Efficacy Study of AADvac1 in Patients With Mild Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Interventions
- Biological: AADvac1Drug: Placebo
- Registration Number
- NCT02579252
- Lead Sponsor
- Axon Neuroscience SE
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AADvac1 AADvac1 AADvac1 is a suspension for subcutaneous injection. AADvac1 is provided in single-use vials. Dosage: 40 µg Axon peptide 108 (coupled to keyhole limpet haemocyanin (KLH)) using aluminium hydroxide (containing 0.5 mg Al3+) as adjuvant, in a phosphate buffer. Patients receive 6 doses in 4-week intervals, and then 5 individual booster doses in 3-month intervals, for a total of 11 doses. Placebo Placebo Placebo is a suspension for subcutaneous injection. Placebo is provided in single-use vials. Dosage: aluminium hydroxide (containing 0.5 mg Al3+), in a phosphate buffer. Patients receive 6 doses in 4-week intervals, and then 5 individual booster doses in 3-month intervals, for a total of 11 doses.
- Primary Outcome Measures
Name Time Method Safety (all-case treatment-emergent adverse events except local reactions) 24 months 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
- Secondary Outcome Measures
Name Time Method Immunogenicity 24 months Alzheimer's Disease Cooperative Study - Activities of Daily Living questionnaire (version for Mild Cognitive Impairment) (ADCS MCI ADL) 24 months 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)
Clinical Dementia Rating (CDR) Sum of Boxes 24 months The domain scores of the standard 6-domain CDR assessment will be summed up to obtain a Sum-of-Boxes score of 0-18
Custom cognitive battery (composite standard score) 24 months 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)
Trial Locations
- Locations (42)
Universitätsklinik für Neurologie
🇦🇹Graz, Steiermark, Austria
Abteilung Psychiatrie und Psychotherapie, LKH Hall
🇦🇹Hall in Tirol, Tirol, Austria
Arzneimittelforschung Leipzig (AFL)
🇩🇪Leipzig, Sachsen, Germany
Universität Heidelberg, Zentralinstitut für Seelische Gesundheit
🇩🇪Mannheim, Germany
Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik fur Psychiatrie und Psychotherapie
🇩🇪München, Germany
Praxis Dr. Klaus Christian Steinwachs
🇩🇪Nürnberg, Germany
Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii
🇵🇱Kraków, Poland
Oddzial Neurologiczny
🇵🇱Olsztyn, Poland
Fakultni nemocnice v Motole
🇨🇿Praha, Czechia
Ordination Dr. Bancher
🇦🇹Horn, Niederosterreich, Austria
Universitätsklinikum Innsbruck
🇦🇹Innsbruck, Tirol, Austria
Fakultni nemocnice u sv. Anny v Brne, Mezinarodni centrum klinickeho vyzkumu (ICRC), Centrum pro kognitivni poruchy, Neuro 2
🇨🇿Brno, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha, Czechia
Neuro Centrum Odenwald
🇩🇪Erbach, Rheinland-Pfalz, Germany
Podlaskie Centrum Psychogeriatrii
🇵🇱Bialystok, Poland
Universitätsklinikum Ulm, Klinik und Poliklinik für Neurologie
🇩🇪Ulm, Germany
Wielospecjalistyczna Poradnia Lekarska Synapsis
🇵🇱Katowice, Poland
Pallmed prowadzacy NZOZ Dom Sue Ryder w Bydgoszczy Centrum Psychoneurologii Wieku Podeszlego
🇵🇱Bydgoszcz, Poland
KO-MED Centra Kliniczne Sp. z o.o.
🇵🇱Lublin, Poland
Care Clinic
🇵🇱Katowice, Poland
University Clinical Centre Maribor
🇸🇮Maribor, Slovenia
EUROMEDIS Sp. z o.o.
🇵🇱Szczecin, Poland
NZOZ Neuro-Kard
🇵🇱Poznan, Poland
Centrum Medyczne NeuroProtect
🇵🇱Warszawa, Poland
Wrocławskie Centrum Alzheimerowskie
🇵🇱Wroclaw, Poland
"Dr. Constantin Gorgos" Psychiatry Hospital Titan
🇷🇴Bucharest, Romania
Neurologicka ambulancia
🇸🇰Banska Bystrica, Slovakia
Univerzitna nemocnica Bratislava, Psychiatricka klinika LFUK a UNB
🇸🇰Bratislava, Slovakia
Nestatna psychiatricka ambulancia
🇸🇰Bratislava, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto, I. Neurologicka klinika LF UK a UNB
🇸🇰Bratislava, Slovakia
Univerzitna nemocnica L Pasteura Kosice, Psychiatricka klinika
🇸🇰Kosice, Slovakia
Centrum zdravia R.B.K., s.r.o., Psychiatricka ambulancia
🇸🇰Svidnik, Slovakia
Fakultna nemocnica s poliklinikou Zilina, Psychiatricke oddelenie
🇸🇰Zilina, Slovakia
NEURES, s.r.o. Neurologicka ambulancia
🇸🇰Krompachy, Slovakia
Pro Mente Sana S.R.O., Psychiatricka Ambulancia
🇸🇰Trencin, Slovakia
Univerzitetni klinični Center Ljubljana, Neurology Clinic
🇸🇮Ljubljana, Slovenia
Skånes Universitetssjukhus Malmö, Minneskliniken
🇸🇪Malmö, Sweden
Sahlgrenska Universitetssjukhuset, Minnesmottagningen
🇸🇪Mölndal, Sweden
Akademiska Sjukhuset I Uppsala, Minnes-och geriatrikmottagningen
🇸🇪Uppsala, Sweden
Karolinska Universitetssjukhuset Huddinge
🇸🇪Stockholm, Sweden
Fakultni nemocnice Hradec Kralove, Neurologicka Klinika
🇨🇿Hradec Kralove, Czechia
Narodni ustav dusevniho zdravi (NÚDZ), Department of cognitive disorders - AD Center
🇨🇿Klecany, Czechia