NCT02579252: ADAMANT

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

Completed Phase 2 Last updated 13 November 2019

What this trial tests

Phase 2 trial testing AADvac1 in Alzheimer's Disease in 208 participants. Completed in 1 June 2019.

Timeline

1 March 2016

Primary endpoint
1 June 2019

1 June 2019

Quick facts

Lead sponsor	Axon Neuroscience SE
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	208
Start date	1 March 2016
Primary completion	1 June 2019
Estimated completion	1 June 2019
Sites	42 locations across Austria, Czechia, Germany, Poland, Romania, Slovakia, Slovenia, Sweden

Drugs / interventions tested

• AADvac1 — full drug profile →
• Placebo

Conditions studied

• Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

Axon Neuroscience SE — full company profile →

Who can join

Adults 50 to 85, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tau-targeting therapies for Alzheimer disease.
   Congdon EE, Sigurdsson EM. · · 2018 · cited 838× · PMID 29895964 · DOI 10.1038/s41582-018-0013-z
2. Roles of tau protein in health and disease.
   Guo T, Noble W, Hanger DP. · · 2017 · cited 710× · PMID 28386764 · DOI 10.1007/s00401-017-1707-9
3. Current and Future Treatments in Alzheimer Disease: An Update.
   Yiannopoulou KG, Papageorgiou SG. · · 2020 · cited 553× · PMID 32165850 · DOI 10.1177/1179573520907397
4. Recent advances in Alzheimer's disease: Mechanisms, clinical trials and new drug development strategies.
   Zhang J, Zhang Y, Wang J, Xia Y, et al · · 2024 · cited 489× · PMID 39174535 · DOI 10.1038/s41392-024-01911-3
5. Alzheimer's disease drug development pipeline: 2019.
   Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008
6. Promoting the clearance of neurotoxic proteins in neurodegenerative disorders of ageing.
   Boland B, Yu WH, Corti O, Mollereau B, et al · · 2018 · cited 422× · PMID 30116051 · DOI 10.1038/nrd.2018.109
7. History and progress of hypotheses and clinical trials for Alzheimer's disease.
   Liu PP, Xie Y, Meng XY, Kang JS. · · 2019 · cited 412× · PMID 31637009 · DOI 10.1038/s41392-019-0063-8
8. Alzheimer's disease drug development pipeline: 2018.
   Cummings J, Lee G, Ritter A, Zhong K. · · 2018 · cited 402× · PMID 29955663 · DOI 10.1016/j.trci.2018.03.009