Trial Outcomes & Findings for Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (NCT NCT03061006)

Enrolled from March 30, 2017 to March 25, 2019

Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation

Incident dementia will be determined by a formal diagnosis of dementia by a neurologist

Determined by measuring the change from baseline to study conclusion on the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog11, with scores ranging from 0 to 70, and higher scores indicating greater impairment) and the Disability Assessment for Dementia (DAD, with scores ranging from 0 to 100, and higher scores indicating less impairment). An increase in ADAS-cog11 of \>30% is considered significant for moderate cognitive decline. In subjects that score \<50% on the DAD, there is a direct correlation with global deterioration scales and scores. Subjects with a 30% decrease in DAD score or those with a score \<50% will be considered to have moderate cognitive decline. These scores will be aggregated and if a patient meets either one of the cognitive decline definitions they will be deemed positive for cognitive impairment.

The Mini-Mental State Examination (MMSE) is commonly used to measure cognitive change over time. Scores on the MMSE range from 0 to 30. Any score of 24 or more indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. We measured the percent change from baseline scores.

The Hachinski Ischemic Scale (HIS) is commonly used clinical tool to differentiate between different types of dementia. Scores on the HIS range from 0 to 18. A score of less than 4 suggests primary dementia. A score of 4-7 is indeterminate. A score more than 7 suggests vascular dementia. We measured percentage change from baseline scores on the HIS.