Effect on the cognitive function of Choline Alfoscerate in combination with donepezil

Comparative study of Choline Alfoscerate as a combination therapy with donepezil

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004660

Enrollment

200

Registered

2020-01-28

Start date

2019-11-25

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : A. Dosing (1) Group 1: donepezil only Group: Donepezil (5mg, 10mg) only dosing (2) Group 2: donepezil + choline alfoscerate Group: Choline alfoscerate 400mg twice daily with donepezil (3) Group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Adult men and women aged 50 to 85 -A person who can understand and make explanations on their own or can get help from an agent (spouse, first-line immediate family). -Those who have been taking stablepezil for more than 3 months with K-MMSE score of 26 or less Donepezil alone or in combination with choline alfoscerate selected Acetyl-L-carnitine and Ginkgo biloba -Those who agree with the study

Exclusion criteria

Exclusion criteria: -Allergies or hypersensitivity to test drugs -Patients with clinically significant digestive system diseases who refuse nausea or vomiting due to the AchE inhibitor family. (Except those who have been resolved by adjusting the dose) -Those who have had surgery or other oral administration that may interfere with food absorption -A significant abnormal finding of liver function or renal function was observed on physical examination after this study, or those diagnosed with liver function or renal function abnormality in other organs (However, there is a chronic disease of liver or kidney but it is controlled. Cases shall not be excluded for this reason) -Have other major psychiatric disorders Patients with unstable physical conditions or diseases that can impede proper evaluation and treatment -Alcohol or drug addicts -If you participate in other clinical trials besides this clinical trial, you cannot know the effects of other clinical trials and drug interactions.

Design outcomes

Primary

Measure	Time frame
MMSE score	—

Secondary

Measure	Time frame
ADAS-cog/noncog;Stroop test score	—

Countries

Korea, Republic of

Contacts

Public ContactWoo-Jin Lee

Seoul National University Hospital

Outcome results