The Efficacy of DL-NBP in Patients With Mild Subcortical Ischemic Vascular Dementia
Status:
Unknown status
Trial end date:
2020-01-31
Target enrollment:
Participant gender:
Summary
This is a 48-week, double-blind, randomized, placebo-controlled study. Sixty-four patients
are randomly assigned to take NBP (600mg per day) or placebo for 48 weeks, with 32 patients
in each treatment group. Anti-dementia treatment-naive patients meet the inclusion/exclusion
criteria are enrolled.
Patients are assigned to NBP will take 200mg tid daily. Patients are visited at baseline, as
well as 4, 12, 24, 36, 48weeks after baseline. Safety data is recorded until an additional 30
days after the last treatment (48 weeks).
The primary outcomes include cognitive function and activities of daily living (ADL). All
subjects are assessed at baseline, 4w, 12w,24w, 36w intermittent visit and 48w endpoint with
the Auditory Verbal Learning Test (AVLT), the Brief Visuospatial Memory Test-Revised
(BVMT-R), the Symbol Digit Modalities Test (SDMT), the Trail Making Test-A/B (TMT-A/B), the
Benton Judgment of Line Orientation (JLO), the verbal fluency test, the Boston Naming Test
(BNT), the Controlled Oral Word Association Test (COWAT), the Stroop test, the Mini-Mental
State Examination (MMSE), the Montreal Cognitive Assessment (MoCA) and the ADL. The secondary
outcomes include the global function and behavioral and psychological symptoms of dementia
(BPSD), which are evaluated with the Clinical Dementia Rating (CDR) and the Neuropsychiatric
Inventory (NPI), respectively. Independent raters who are blinded to patients' distribution
are assigned to assess the participants.
The exploratory outcomes are markers of vascular regulation, including circulating
endothelial progenitor cells (EPCs), white matter hyperintensities (WMH) on MRI, cerebral
blood flow (CBF) measured with transcranial Doppler (TCD) and arterial spin labeling (ASL)
MRI, and parameters of carotid duplex ultrasonic (CDU). In addition, apolipoprotein E (APOE)
polymorphism and plasma biomarkers are also detected.
Safety are assessed at each visit.