Aricept

1
Aricept Clinical Studies in VaD

• Clinical Studies designed to focus on a specific
  patient population (NINDS-AIREN Criteria)
• dementia memory 2 other domain
• identifiable by clinical and radiologic criteria
• CVD documented by CT or MRI
• significant Vascular Risk Factors
• NO previous documented diagnosis of AD
• Parallel group design 24 weeks Double-blind OL
  Extension

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Clinically Relevant Population

• Patients with Probable or Possible Dementia with
  CVD
• Patients with a clinical history of
• Stroke, Intracranial Hemorrhage, WMD
• Risk Factors of diabetes mellitus, hypertension,
  atherosclerosis, cardiovascular disease
• Patients who are evaluated for the first time
  with dementia who have evidence for CVD are
  eligible

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NINCDS-ADRDA Criteria
NINDS-AIREN Criteria
Possible VaD

• Dementia
• CVA not required
• Onset/Progression variable
• Neuroimaging positive for CVD
• Co-morbidities may be present

Probable AD
Probable VaD

• Dementia
• Gradual onset
• Continuous Progression
• Neuroimaging negative for CVD
• No significant comorbidity (i.e. CAD, DM,CVD)

• Dementia
• Onset within 3 month of CVA
• Stepwise Progression
• Focal Neurological Findings
• Neuroimaging positive for CVD
• Significant co-morbidities present

• Neuroimaging
• Cortical Infarcts
• Subcortical Infarcts
• Multiple lacunes
• Extensive WMD

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Outcome Measures
5
Cognitive Domains in VaD and AD Looi, JCL and
Sachdev, P.S. Neurology 53670-678 (1999)
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Reasons for Screen Failure in VaD Trial
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Conclusions

• NINDS-AIREN criteria selects a different
  population from Probable AD
• Clinical Characteristics different from AD
• Neuroimaging abnormal
• Outcome measures (ADAS-cog, CIBIC-Plus)
  appropriate because cognitive deficits are
  similar
• Population can be identified by clinicians
  pursuing a dementia work-up