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Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment

NCT02982603 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2018-10-23

No results posted yet for this study

Summary

This study is a 52-weeks, multicenter, randomized, double-blind, double- placebo, parallel controlled phase VI trial being carried out in 20 centers around China. The study population includes amnestic mild cognitive impairment patients (planned a total of 360) aged 55-85 in both gender. Participants will be randomly allocated to Qinggongshoutao bolus (7g per time,2 times per day) and placebo identified to Ginkgo biloba (Ginaton), Ginkgo biloba (Ginaton) (80mg per time, 2 times per day) and placebo identified to Qinggongshoutao bolus, or placebo identified to Qinggongshoutao bolus and placebo identified to Ginkgo biloba (Ginaton) for a 52-weeks double-blind treatment period. The primary outcome measure is change from baseline in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental State Examination(MMSE), Delayed Story Recall(DSR), Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is being assessed by observing side effects and adverse reaction during the entire treatment period. Statistical analysis will be conducted according to per-protocol population and intend-to-treat population and the safety will be analyzed in safety set.

Conditions

Interventions

DRUG

Qinggongshoutao Bolus

Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761

DRUG

Ginkgo Biloba Extract 761

Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761

DRUG

Placebos

Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba

Sponsors & Collaborators

  • Dongzhimen Hospital, Beijing

    lead OTHER

Principal Investigators

  • Jinzhou Tian, M.D,PhD · Dongzhimen Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02982603 on ClinicalTrials.gov