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

Phase 4

• Conditions: Alzheimer Disease
• Interventions: Drug: Placebo; Drug: Choline alfoscerate

• Registration Number: NCT02648906
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02
• Primary Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. 56~90 male and female
2. Mini-Mental State Evaluation (MMSE) between 24 and 12
3. Score ≥ 2 at the New Rating Scale for Age-related White Matter Changes (ARWMC), the rating scale of cerebral ischemic injury evaluated with MRI
4. Score 0.5, 1, 2 at CDR
5. 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.
6. donepezil 10mg from 3 months ago, dose not changed during clinical trials
7. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

Exclusion Criteria

1. Subjects allergic to or sensitive to the Investigational Product or applicable ingredients
2. 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
3. subject that can't be evaluated with ADAS-cog, MMSE, NPI, ADL, CDR, Attention Questionnaire Scale etc.
4. Asthma, COPD
5. Decompensated heart disease
6. Chronic renal failure or chronic liver disease
7. Malignant tumor
8. 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Drug: Donepezil only
Choline alfoscerate	Choline alfoscerate	Drug: Choline alfoscerate and Donepezil concomitant administration

Primary Outcome Measures

Name	Time	Method
change of ADAS-cog score compared with Baseline	48 weeks	Primary outcome will be evaluated with ADAS-cog questionnaire 48 weeks after taking investigational product.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Sungnam, Korea, Republic of