To participate, visit ClinicalTrials.gov for registration!

Sponsor: Axovant Sciences Ltd

Research Aims

The aims were to evaluate the efficacy of intepirdine (RVT-101) in combination with donepezil, compared to placebo, in patients with mild to moderate Alzheimer’s disease.

How the Core Was Integral to the Study

• Recruited (14 patients in 6 months) and retained patients (100% retention rate) with Alzheimer’s disease, who are very challenging to recruit and retain. Named the top recruitment site in Asia for this study.
• Obtained regulatory and safety approvals, as described in Project 1
• Performed the following assessments to help determine efficacy for cognitive function:
  • Alzheimer’s Disease Assessment Scale – Cognitive 11 (ADAS-COG 11)
  • Alzheimer’s Disease Co-operative Study – Activities of Daily Living (ADCS-ADL)
• Performed the following assessments to help determine efficacy for global functioning:
  • Clinician Interview-Based Impression of Change Plus (CIBIC+)
  • EuroQol-5D (EQ-5D)
  • Dependence Scale (DS)
• Performed the following scales to evaluate behavioural and mood symptoms
  • Neuropsychiatric Inventory (NPI)
  • Columbia-Suicide Severity Rating Scale (C-SSRS)
• Performed the following assessments to assess the caregiver burden
  • Resource Utilization in Dementia-lite (RUD-lite)

Results

Intepirdine, in combination with donepezil, was not more effective than placebo for patients with mild to moderate Alzheimer’s disease.

Find out more!

Visit our Menu of Services page to find out more about our services and prices.