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Table 1 Trial designs used in included randomised controlled trials to try to demonstrate disease-modification

From: A review of clinical trial designs used to detect a disease-modifying effect of drug therapy in Alzheimer’s disease and Parkinson’s disease

  Type of trials Wash-in analysis Wash-out analysis Delayed-start trial design Long-term follow-up Biomarkers (primary or secondary outcome measures) Time-to-event outcomes
Imaging CSF Blood Other
n % n % n % n % n % n % n % n % n %
AD Published (n = 59) 3 5 11 19 7 12 45 76 27 46 17 29 6 10 2 3 3 5
Planned, ongoing & unpublished (n = 25) 0 0 0 0 2 8 22 88 12 48 10 40 4 16 0 0 1 4
All (n = 84) 3 4 11 13 9 11 67 80 39 46 27 32 10 12 2 3 4 5
PD Published (n = 36) 11 31 17 47 7 19 25 69 12 33 0 0 1 3 0 0 18 50
Planned, ongoing & unpublished (n = 8) 0 0 3 38 0 0 4 50 4 50 1 13 0 0 0 0 3 38
All (n = 44) 11 25 20 45 7 16 29 66 16 36 1 2 1 2 0 0 21 48
  1. (CSF Cerebrospinal fluid. ‘Other’ biomarkers include a urine biomarker and electroencephalography used in published AD trials)