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

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Alzheimer Disease

Treatments: Drug: Choline alfoscerate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02648906

DWB_GTM001

Details and patient eligibility

About

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

Enrollment: 128 estimated patients

Sex: All

Ages: 56 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups, including a placebo group

Choline alfoscerate

Experimental group

Description:

Drug: Choline alfoscerate and Donepezil concomitant administration

Treatment:

Drug: Choline alfoscerate

Placebo

Placebo Comparator group

Description:

Drug: Donepezil only

Treatment:

Drug: Placebo