Overview

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

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Treatments:
Choline
Donepezil
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