The primary objective of this study was to assess the efficacy and safety of Gingko biloba film-coated tablets in improving cognitive function and neuropsychological functioning of middle-aged cognitively intact adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Changes from baseline of the cognitive test/CDR (Cognitive Drug Research) factor "Power of Attention)
Time frame: pre-dose and 2, 4, 6 hours post-dosing at baseline and day 56
Changes from baseline in CDR factors
Time frame: pre-dose and 2, 4, 6 hours post-dosing at baseline, days 28 and 56
Changes from baseline in Stroop Colour and Word Test
Time frame: Baseline and day 56
Changes from baseline in the Selective Reminding Test
Time frame: Baseline and day 56
Changes from baseline in the Trail Making Test (Part A and B)
Time frame: Baseline and day 56
Number of patients with adverse events
Time frame: up to 56 days
Number of patients with clinically significant changes in vital signs
Time frame: Baseline, days 28 and 56
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline and day 56
Assessment of tolerability by subject on a 4-point scale
Time frame: Days 28 and 58
Assessment of tolerability by investigator on a 4-point scale
Time frame: Days 28 and 58
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