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

Daewoong Pharmaceutical Co. LTD.1 site in 1 country128 target enrollmentJuly 2015

ConditionsAlzheimer Disease

InterventionsCholine alfoscerate Placebo

DrugsCholine alfoscerate Placebo

Overview

Phase: Phase 4
Intervention: Choline alfoscerate
Conditions: Alzheimer Disease
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 128
Locations: 1
Primary Endpoint: change of ADAS-cog score compared with Baseline
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

November 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

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
•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