Essay: Patients eligibility test
Age, residential location of patients, average socio-cultural and education levels, and spontaneous reporting of memory complaints were the main considerations for patient eligibility. Visual acuity and presence of drusen, abnormal pigmentary epithelium and vascularisation were considered in the diagnostic criteria for age related muscular degeneration. Apolipoprotein E, a genotypic determinant for treatment response was taken from blood samples while urine samples were taken to determine isoprostan, a potential biochemical surrogate marker of outcome. Spontaneously reported adverse effects were recorded for safety evaluation purposes (p.407).
In the treatment process, subjects were randomized at the validation visit by receiving EGb 761 or a matching placebo. Blinding was ensured by identical appearance of placebo and active drug while color marking was ensured by using a brown pigment. Behavioral assessment was through the administration of neuropsychological tests for assessment of cognitive function; the cognitive status was also evaluated fusing MMS and CDR; Functional status was evaluated using the Instrumental Activities of Daily Living Questionnaire. Other assessments involved balance disturbances, assessed by determining one’s ability to stand on one leg, posturography and diagnostic criteria for sarcopenia (pp.407-409).
Outcome measures entailed independent adjudication by four clinicians not connected to the study to ascertain uniform case results. Changes in CDR dementia scores and changes in performance on neuropsychological tests were considered in the secondary outcome measures.