24 Months Safety and Efficacy Study of AADvac1 in Patients With Mild Alzheimer's Disease (ADAMANT)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||A 24 Months Randomised, Placebo-controlled, Parallel Group, Double Blinded, Multi Centre, Phase 2 Study to Assess Safety and Efficacy of AADvac1 Applied to Patients With Mild Alzheimer's Disease|
- Safety (all-case treatment-emergent adverse events except local reactions) [ Time Frame: 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
- Clinical Dementia Rating (CDR) Sum of Boxes [ Time Frame: 24 months ]
- Custom cognitive battery (composite standard score) [ Time Frame: 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)
- Alzheimer's Disease Cooperative Study - Activities of Daily Living questionnaire (version for Mild Cognitive Impairment) (ADCS MCI ADL) [ Time Frame: 24 months ]
- Immunogenicity [ Time Frame: 24 months ]
- Exploratory: Fludeoxyglucose Positron Emission Tomography (FDG PET) assessment of brain metabolism (change in cerebral glucose metabolic rate expressed as Standardised Uptake Value Ratio [SUVR] change, multiple regions of interest) [ Time Frame: 24 months ]
- Exploratory: MRI volumetry [ Time Frame: 24 months ]
- Exploratory: Cerebrospinal fluid (CSF) biomarkers [ Time Frame: 24 months ]
|Study Start Date:||March 2016|
|Estimated Study Completion Date:||February 2019|
|Estimated Primary Completion Date:||February 2019 (Final data collection date for primary outcome measure)|
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 Comparator: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02579252
|Contact: Matej Ondrus, MD||00421 220 921 email@example.com|
|Contact: Petr Novak, MD, PhD||00421 220 921 firstname.lastname@example.org|
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|Principal Investigator:||Reinhold Schmidt, Prof. MD.||Medical University, Graz, Austria|