A Clinical Trial for an Evaluation of Choline Alfoscerate and Donepezil for Cognitive Improvements of Patients With Cerebrovascular Injury in Alzheimer Patients

November 1, 2016 updated by: Daewoong Pharmaceutical Co. LTD.
The purpose of this study is to evaluate efficacy and safety of Choline alfoscerate and Donepezil for cognitive improvements of patients with cerebrovascular injury in Alzheimer patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Sungnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 56~90 male and female
  2. Mini-Mental State Evaluation (MMSE) between 24 and 12
  3. Score ≥ 2 at the New Rating Scale for Age-related White Matter Changes (ARWMC), the rating scale of cerebral ischemic injury evaluated with MRI
  4. Score 0.5, 1, 2 at CDR
  5. presence of at least two of the following vascular risk factors: hypertension, diabetes, obesity, ischemic heart disease, dyslipidemia, hyperhomocysteinemia, smoking, previous cerebrovascular events and familiar history of cardio-cerebrovascular diseases.
  6. donepezil 10mg from 3 months ago, dose not changed during clinical trials
  7. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

Exclusion Criteria:

  1. Subjects allergic to or sensitive to the Investigational Product or applicable ingredients
  2. subject who has taken below medication 1 month before screening 1) Cholinesterase Inhibitors 2) NMDA receptor antagonists 3) blood circulation supplements 4) Acetyl-L-Carnitines 5) Nicergoline 6) Subject who has taken another medication that can affect the result of primary outcome
  3. subject that can't be evaluated with ADAS-cog, MMSE, NPI, ADL, CDR, Attention Questionnaire Scale etc.
  4. Asthma, COPD
  5. Decompensated heart disease
  6. Chronic renal failure or chronic liver disease
  7. Malignant tumor
  8. Subject that cant' be followed up for 12 months after Investigational drug was taken.

9 Subjects who are pregnant, lactating or who plan to be pregnant during the clinical period or females of child bearing years who do not use available contraceptive methods 10. Subject who has taken other clinical or licensed medication from another clinical trial within 30 days prior screening period 11.Other subjects who are deemed not to be appropriate for this clinical study in the discretion of investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Choline alfoscerate

Drug: Choline alfoscerate and Donepezil

concomitant administration
Drug: Choline alfoscerate
Placebo Comparator: Placebo
Drug: Donepezil only
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of ADAS-cog score compared with Baseline
Time Frame: 48 weeks
Primary outcome will be evaluated with ADAS-cog questionnaire 48 weeks after taking investigational product.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DWB_GTM001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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