ANAVEX2-73-AD-004

• Research type

  Research Study

• Full title

  A Phase 2b/3, Double-Blind, Randomised, Placebo-Controlled 48 week Safety and Efficacy trial of ANAVEX2-73 for the Treatment of Early Alzheimer’s Disease (AD)

• IRAS ID

  275312

• Contact name

  Christopher Missling

• Contact email

  cmissling@anavexcorp.com

• Sponsor organisation

  Anavex Germany GmbH

• Eudract number

  2019-003302-27

• Duration of Study in the UK

  2 years, 6 months, 0 days

• Research summary

  Summary of Research
  This is a Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition
  and functioning after 48 weeks of daily treatment. Additional outcome measures include refined measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in daily functioning of participants and changes in caregiver burden, as well as changes in quality of life measures of both, patients and caregivers during treatment with ANAVEX2-73. In addition, safety assessments, pharmacokinetic (PK) assessments and blood markers of AD pathophysiology before and after treatment will be performed.
  Randomisation to 3 parallel groups (placebo, ANAVEX2-73 30 mg/day, and ANAVEX2-73 50 mg/day). This includes gradual 3-week titration period with incremental increase of 10 mg per week (Week 1: placebo, or (ANAVEX2-73) 10 mg/day; Week 2: placebo or 20 mg/day and then Week 3: placebo or 30 mg/day). Then a maintenance period (Week 4 to Week 48): of placebo, or 30mg/day or 50mg/day ANAVEX2-73.
  The double-blind phase is followed by a 4-week follow-up period with down titration.
  Assessments include: 12 Lead ECG, MRI, blood samples for PK and biomarker and DNA, laboratory blood tests, Urine dipstick, questionnaires (ADAS-Cog, ADCS-ADL, CDR-SB, MMSE, FCSRT, QoL, ZBI) and sleep assessment

  Summary of Results
  ANAVEX2-73 appeared to be generally safe and tolerated in the safety population of study
  ANAVEX2-73-AD-004. The incidence of treatment emergent AEs was similar in the
  ANAVEX2-73 and placebo arms with dizziness being the most common treatment emergent
  AEs and AEs were predominantly mild or moderate. No clinically significant changes in vital
  signs, laboratory values and ECG parameters were observed. Safety findings in the study were
  consistent with the known safety profile of ANAVEX2-73. Treatment with ANAVEX2-73
  reduced clinical decline on the global cognitive and functional scales over 48 weeks compared
  with placebo

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  19/LO/1898

• Date of REC Opinion

  22 Jan 2020

• REC opinion

  Further Information Favourable Opinion