Alzheimer’s digest - 2021

Alzheimer’s digest - 2021

Axon Neuroscience published ADAMANT Phase 2 study of AAdvac1

AADvac1 (Alzheimer’s tau vaccine) – Axon Neuroscience

  • Trial details: ADAMANT; Phase 2 in mild Alzheimer’s disease; N= 196; AADvac1 40 µg SC Q4W (6 vaccine doses) to complete the 6-dose primary vaccination series (Visit V02 to V07), booster vaccinations with AADvac1 were administered at intervals of approximately 3 months (14 weeks) thereafter, at visits V08a (Week 34), V10 (Week 48), V11a (Week 62), V13 (Week 76) and V14a (Week 90) vs placebo; Primary outcomes: TEAE; PCD: Jun 2019; Completed; Location: EU
  • Results: (N= 196)
    • AADvac1 decreased the accumulation of Neurofilament Light Chain (NfL) in the blood by 58% (p value=0.004) and reduced CSF biomarker phosphotau–T217
    • In a subgroup (N=109), when compared with placebo, AADvac1 significantly slowed the clinical decline by 27% (p value=0.048) and functional decline by 30%
    • Cognitive and functional tests were found to be insignificant on the whole study sample. Clinical Dementia Rating- Sum of the Boxes scale adjusted mean point difference-0.360 (95% CI −1.306, 0.589); custom cognitive battery adjusted mean z-score difference of 0.0008 (For full story click here)

In patients with confirmed Alzheimer's disease biomarker profile (amyloid and tau positivity), AADvac1 demonstrated significant slowing of clinical and functional decline as measured by CDR-SB and ADCS-MCI-ADL

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CI Scientists Commentary:

  • AADvac1 is a clinically advanced tau therapy vaccine in development. The vaccine consists of a synthetic peptide derived from amino acids 294 to 305 of the tau sequence
  • While AADvac1 was to able clear the abnormal tau protein from the brain, it is yet to confirm improvement in brain function
  • Unlike other tau-based therapeutics, this vaccine targets both the formation of pathological tau proteins (truncated and oligomerized forms) and the spread of those already formed

– Dr. Kowndinya, CI Scientists