NCT02648906

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

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for phase_4 alzheimer-disease

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

January 5, 2016

Last Update Submit

November 1, 2016

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • change of ADAS-cog score compared with Baseline

    Primary outcome will be evaluated with ADAS-cog questionnaire 48 weeks after taking investigational product.

    48 weeks

Study Arms (2)

Choline alfoscerate

EXPERIMENTAL

Drug: Choline alfoscerate and Donepezil concomitant administration

Drug: Choline alfoscerate

Placebo

PLACEBO COMPARATOR

Drug: Donepezil only

Drug: Placebo

Interventions

Choline alfoscerateDRUG
Choline alfoscerate
PlaceboDRUG
Placebo

Eligibility Criteria

Age56 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \~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

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Sungnam, South Korea

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Glycerylphosphorylcholine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GlycerophosphatesTriose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesGlycerophospholipidsPhosphatidic AcidsPhospholipidsMembrane LipidsLipidsLecithinsPhosphatidylcholines

Central Study Contacts

Jina Song

CONTACT

82-2-550-8865jnsong058@daewoong.co.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 7, 2016

Study Start

July 1, 2015

Primary Completion

November 1, 2018

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

KR(1)