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. 2021 Jan 25;2020:717–726.

Table 3.

Eligibility criteria of a hypothetical trial constructed based on NCT00478205.

Num Short Name Inclusion/ Exclusion Criteria Definitions
1 Age Inclusion age at first donepezil date 45 - 90
2 Donepezil days Inclusion days on donepezil >= 90 days
3 Visual/hearing Impairment Exclusion patients with visual impairment or hearing impairment*
4 Cardiac diseases Exclusion patients with acute myocardial infraction, atrial fibrillation,
heart failure, or ischemic heart disease*
5 Uncontrolled Hypertension Exclusion patients with hypertension and have systolic blood
pressure > 140 or diastolic blood pressure > 90 in recent 3 months*
6 Uncontrolled diabetes Exclusion patients with diabetes and have HbA1c > 7 % in recent 3
months*
7 Other AD treatments Exclusion patients taken any of Tacrine, Pyridostigmine,
Galantamine, Isoflurophate, Demecarium, Physostigmine, Rivastigmine, Edrophonium, or Ambenonium
8 Dementias other than AD Exclusion patients had no diagnosis of AD but had diagnosis of other
dementias
9 Parkinsons disease Exclusion patients diagnosed with Parkinsons disease
10 Schizophrenia Exclusion patients with schizophrenia*
11 Depression Exclusion patients with depression*
12 Sleep disorder Exclusion patients diagnosed with sleep disorder
13 Drug use disorders Exclusion patients with drug use disorders*
14 Alcohol use disorders Exclusion patients with alcohol use disorders*
15 Conditions affect absorption,
distribution, or metabolism of the study medication
Exclusion patients diagnosed with any of inflammatory bowel
disease, gastric or duodenal ulcers, or hepatic disease
16 Cancer Exclusion patients with a history of cancer (does not include basal or
squamous cell carcinoma of the skin, benign prostatic hyperplasia) within 5 years*
17 Use antidepressants Exclusion patients prescribed with any of amitriptyline,
clomipramine, doxepin, imipramine, trimipramine, protriptyline, amoxapine, desipramine, or nortriptyline
18 Fecal/urinary incontinence Exclusion patients diagnosed with fecal or urinary incontinence
*

These criteria were constructed based on CMS CCW chronic condition algorithms.