24 Months Safety and Efficacy Study of AADvac1 in Patients With Mild Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Biological: AADvac1; Drug: 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.

Study Timeline

• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Study Start: 2016-03
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

Not provided

Exclusion Criteria

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)

Ordination Dr. Bancher; 🇦🇹 Horn, Niederosterreich, Austria

Universitätsklinik für Neurologie; 🇦🇹 Graz, Steiermark, Austria

Abteilung Psychiatrie und Psychotherapie, LKH Hall; 🇦🇹 Hall in Tirol, Tirol, 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

Fakultni nemocnice Hradec Kralove, Neurologicka Klinika; 🇨🇿 Hradec Kralove, Czechia

Narodni ustav dusevniho zdravi (NÚDZ), Department of cognitive disorders - AD Center; 🇨🇿 Klecany, Czechia

Vseobecna fakultni nemocnice v Praze; 🇨🇿 Praha, Czechia

Fakultni nemocnice v Motole; 🇨🇿 Praha, Czechia

Neuro Centrum Odenwald; 🇩🇪 Erbach, Rheinland-Pfalz, Germany

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