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Study to Explore the Optimal Dosage/Administration in Alzheimer's Disease

NCT01715350 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2016-04-18

No results posted yet for this study

Summary

The investigators intend to perform exploratory evaluation of the treatment effectiveness and safety of PM012 Tablet of PuriMED Co., Ltd. at 2 doses in Korean patients with mild to moderate dementia of Alzheimer's type. To achieve this, this study aims to compare each dose with placebo control for the efficacy and safety to explore the clinically optimal dose of PM012 Tablet for therapeutic confirmatory (phase 3) clinical studies.

Conditions

Interventions

DRUG

PM012

* The drug will be taken with water within 30 minutes after breakfast and supper. * 650mg/1 tablet, PO, 12weeks

DRUG

Placebo

* The drug will be taken with water within 30 minutes after breakfast and supper. * 650mg/1 tablet, PO, 12weeks

Sponsors & Collaborators

  • ADM Korea Inc

    collaborator INDUSTRY

  • VTBIO Co. LTD

    lead INDUSTRY

Principal Investigators

  • Seoung-Hun Cho, M.D. · Kyung Hee University Oriental Medicine Hospital

  • Chang-Uk Lee, M.D. · The Catholic University of Korea

  • Hyun-Kook Lim, M.D. · Saint Vincent's Hospital, Korea

  • Jun-Hong Lee, M.D. · National Health Insurance Service Ilsan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-09-30
Completion
2015-06-30

Countries

  • South Korea

Study Locations

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Entities

Drugs
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 NCT01715350 on ClinicalTrials.gov