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Efficacy and Safety of 1612 Capsules in aMnestic Mild Cognitive Impairment

NCT02982642 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2021-03-04

No results posted yet for this study

Summary

This study is a 52-weeks, multicenter, randomized, double-blind, placebo controlled, parallel trial which will be carried out in 15 centers around China. The study population includes amnestic mild cognitive impairment patients (planned a total of 240) aged 55-85 in both gender. Participants will be randomly allocated to 1612 capsules (1.14g per time, 3 times per day) or placebo 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 test (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

1612 capsule

Subjects will be assigned 1612 capsule,3 capsules per time(0.38g per capsule), 3 times per day.1612 capsule is a Chinse herbal medicine,which can tonification of spleen and kidney, mainly contains shudihuang(Rehmannia glutinosa),shanyao(Dioscorea opposita),shichangpu(Uncaria rhynchophylla)and so on,

DRUG

Placebos

Subjects will be assigned placebo identified to 1612 capsule,3 capsules per time, 3 times per day

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
2017-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

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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 NCT02982642 on ClinicalTrials.gov