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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02648906
Recruitment Status : Unknown
Verified November 2016 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was:  Recruiting
First Posted : January 7, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Choline alfoscerate Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2015
Estimated Primary Completion Date : November 2018


Arm Intervention/treatment
Experimental: Choline alfoscerate

Drug: Choline alfoscerate and Donepezil

concomitant administration

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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   56 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648906


Contacts
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Contact: Jina Song 82-2-550-8865 jnsong058@daewoong.co.kr

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Sungnam, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT02648906    
Other Study ID Numbers: DWB_GTM001
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents