NCT03441516

Brief Summary

This study will evaluate the performance of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) in patients with Alzheimer's disease (AD).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
79

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 19, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

1.2 years

First QC Date

February 5, 2018

Last Update Submit

December 20, 2020

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • ADAS-cog

    To evaluate cognitive function

    At 24 weeks

Secondary Outcomes (6)

  • ADAS-cog

    At 12 weeks

  • K-MMSE (Korean version of Mini-Mental State Examination)

    At 12 and 24 weeks

  • FAB (Frontal Assessment Battery)

    At 12 and 24 weeks

  • S-IADL (Seoul-Instrumental Activities of Daily Living)

    At 12 and 24 weeks

  • CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory)

    At 12 and 24 weeks

  • +1 more secondary outcomes

Study Arms (2)

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

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.
Aripezil® Tab.DRUG

Donepezil 10 mg Oral Tablet qd for 24 weeks

Aripezil® Tab.

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dong-A University Hospital

Busan, South Korea

Location

Gyeongsang National University Hospital

Busan, South Korea

Location

Inje University Busan Paik Hospital

Busan, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, South Korea

Location

Pusan National University Yangsan Hospital

Busan, South Korea

Location

Samsung Changwon Hospital

Busan, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 22, 2018

Study Start

April 19, 2018

Primary Completion

July 4, 2019

Study Completion

December 31, 2021

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations

KR(6)