Effect of Choline Alphoscerate on Cognitive Function in A... | NCT03441516

Studies
Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia

NCT03441516

Sponsor

Yuhan Corporation

Status

Unknown status

Last Update Posted

Dec 22, 2020Actual

Enrollment

79Actual

Phase

Phase 4

Conditions

Alzheimer's Disease

Interventions

Alfoatirin® Tab. + Aripezil® Tab.
Aripezil® Tab.

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2018Actual

Primary Completion Date

Jul 4, 2019Actual

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Feb 5, 2018

First Submission Date that Met QC Criteria

Feb 20, 2018

First Posted Date

Feb 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2020

Last Update Posted Date

Dec 22, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alfoatirin® Tab. + Aripezil® Tab.	Experimental	Choline Alphoscerate 400mg bid + Donepezil 10mg qd for 24 weeks	Drug: Alfoatirin® Tab. + Aripezil® Tab.
Aripezil® Tab.	Active Comparator	Donepezil 10mg qd for 24 weeks	Drug: Aripezil® Tab.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alfoatirin® Tab. + Aripezil® Tab.	Drug	Choline Alphoscerate 400 mg Oral Tablet bid + Donepezil 10 mg Oral Tablet qd for 24 weeks	Alfoatirin® Tab. + Aripezil® Tab.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ADAS-cog	To evaluate cognitive function	At 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
ADAS-cog	To evaluate cognitive function	At 12 weeks
K-MMSE (Korean version of Mini-Mental State Examination)	To evaluate cognitive function

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

50 - 90 years of age
Clinical diagnosis of dementia of the Alzheimer type determined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
A diagnosis of probable Alzheimer's Disease, or mild to moderate AD determined by NIA-AA (National Institute on Aging and the Alzheimer's Association) criteria
K-MMSE score of 12 - 26
Global Clinical Dementia Rating (CDR) score of 0.5 - 2
Patient taking 10 mg of donepezil per day for a minimum of 12 weeks with a stable dose, not taking other brain pills including choline alfoscerate for at least 2 weeks from screening. Drugs that are likely to affect cognition are permissible if the dose is regular and stable for at least 2 weeks before screening and if the treatment continues for the duration of the trial.

Exclusion Criteria:

Subject suspected of dementia due to organic causes other than Alzheimer's type dementia
Other degenerative brain diseases or major mental illnesses such as major depression, bipolar disorder, alcohol/substance abuse or dependence, delirium
Hypersensitive to choline alfoscerate, donepezil hydrochloride, or piperidine derivatives or the components of this drug
Subject who has contraindications as listed in the SPC of choline alfoscerate or donepezil hydrochloride
Other than the above who is deemed to be ineligible to participate in the trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Dong-A University Hospital		Busan			South Korea
Gyeongsang National University Hospital

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases