24 Months Safety and Efficacy Study of AADvac1 in Patients With Mild Alzheimer's Disease (ADAMANT)
|ClinicalTrials.gov Identifier: NCT02579252|
Recruitment Status : Active, not recruiting
First Posted : October 19, 2015
Last Update Posted : August 29, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Biological: AADvac1 Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
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.
- 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 ]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) [ 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 ]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)
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579252
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|Principal Investigator:||Reinhold Schmidt, Prof. MD.||Medical University, Graz, Austria|