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Table 2 NorAD trial schedule of visits

From: Noradrenergic Add-on Therapy with Extended-Release Guanfacine in Alzheimer’s Disease (NorAD): study protocol for a randomised clinical trial and COVID-19 amendments

Procedures (following pre-screening visit)

Screening visit

0 (W0)

1 (W1)

2 (T/C) (W2)

3 (W4)

4 (W8)

5 (W12)

6 (T/C) (W13)

MMSE

X

X

    

X

 

ECG

X

X

X

     

U&E, LFT

X

       

HR, s/s BP

X

X

X

 

X

X

X

 

≥ 3 months treatment with ChEI

X

X

      

Consent

X

X

      

Medical history

X

       

Inclusion/exclusion

X

X

      

Randomisation

 

X

      

ADAS-Cog

 

X

  

X

 

X

 

Trails A and B

 

X

  

X

 

X

 

Digit-symbol substitution

 

X

  

X

 

X

 

TEA (map search and elevator counting)

 

X

  

X

 

X

 

CANTAB-RVP

 

X

  

X

 

X

 

NPI

 

X

  

X

 

X

 

ZBI

 

X

  

X

 

X

 

ADCS-ADL

 

X

  

X

 

X

 

ESS

 

X

X

 

X

X

X

 

SEQ

  

X

X

X

X

X

X

AE/CM

  

X

X

X

X

X

X

Unused dose counts

  

X

 

X

X

X

 

Dispensing

 

X

X

 

X

X

  
  1. There is a ± 3-day window for each assessment
  2. ADAS-Cog Alzheimer’s Disease Assessment Scale-Cognitive Subscale, ADCS-ADL Alzheimer’s Disease Co-operative Study - Activities of Daily Living Inventory, AE/CM adverse event/concomitant medication, CANTAB-RVP Cambridge Neuropsychological Automated Battery-Rapid Visual Information Processing, ChEI cholinesterase inhibitor, ECG electrocardiogram, ESS Epworth Sleepiness Scale, HR heart rate, LFT liver function test, MMSE Mini-Mental State Examination, NPI Neuropsychiatric Inventory, s/s BP sitting and standing blood pressure, SEQ Side-Effect Questionnaire, TEA Test of Attention, U&E urea and electrolytes, W Week, ZBI Zarit Burden Interview
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Trials

ISSN: 1745-6215