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

Primary Purpose

Alzheimer Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Choline alfoscerate
Placebo
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

56 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Choline alfoscerate

Placebo

Arm Description

Drug: Choline alfoscerate and Donepezil concomitant administration

Drug: Donepezil only

Outcomes

Primary Outcome Measures

change of ADAS-cog score compared with Baseline
Primary outcome will be evaluated with ADAS-cog questionnaire 48 weeks after taking investigational product.

Secondary Outcome Measures

Full Information

First Posted
January 5, 2016
Last Updated
November 1, 2016
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT02648906
Brief Title
A Clinical Trial for an Evaluation of Choline Alfoscerate and Donepezil for Cognitive Improvements of Patients With Cerebrovascular Injury in Alzheimer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Choline alfoscerate
Arm Type
Experimental
Arm Description
Drug: Choline alfoscerate and Donepezil concomitant administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Donepezil only
Intervention Type
Drug
Intervention Name(s)
Choline alfoscerate
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
change of ADAS-cog score compared with Baseline
Description
Primary outcome will be evaluated with ADAS-cog questionnaire 48 weeks after taking investigational product.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
56 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 56~90 male and female Mini-Mental State Evaluation (MMSE) between 24 and 12 Score ≥ 2 at the New Rating Scale for Age-related White Matter Changes (ARWMC), the rating scale of cerebral ischemic injury evaluated with MRI Score 0.5, 1, 2 at CDR 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. donepezil 10mg from 3 months ago, dose not changed during clinical trials A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints Exclusion Criteria: Subjects allergic to or sensitive to the Investigational Product or applicable ingredients 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 subject that can't be evaluated with ADAS-cog, MMSE, NPI, ADL, CDR, Attention Questionnaire Scale etc. Asthma, COPD Decompensated heart disease Chronic renal failure or chronic liver disease Malignant tumor 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jina Song
Phone
82-2-550-8865
Email
jnsong058@daewoong.co.kr
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Sungnam
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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