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

Alzheimer Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02648906
• Other study ID #: DWB_GTM001
• Status: Recruiting
• Phase: Phase 4
• First received: January 5, 2016
• Last updated: November 1, 2016
• Start date: July 2015

Study information

• Verified date: November 2016
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Jina Song
• Phone: 82-2-550-8865
• Email: jnsong058[@]daewoong.co.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 56 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Choline alfoscerate

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Sungnam

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of ADAS-cog score compared with Baseline	Primary outcome will be evaluated with ADAS-cog questionnaire 48 weeks after taking investigational product.	48 weeks	No