- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05383183
Efficacy and Safety of ChOline ALfoscerate in Patient With Mild to Moderate Alzheimer's Disease (COALA)
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Patients With Mild to Moderate Alzheimer's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Yunjae Ahn
- Phone Number: +82-550-8191
- Email: yjahn@daewoong-bio.co.kr
Study Locations
-
-
-
Changwon, Korea, Republic of
- Recruiting
- Changwon Fatima Hospital
-
Contact:
- Jay-Cheol Kwon
-
Incheon, Korea, Republic of
- Recruiting
- Gachon University Gil Medical Center
-
Contact:
- Ki Hyung Park
-
Seongnam, Korea, Republic of
- Recruiting
- Cha Bundang Medical Center
-
Contact:
- Hyun Sook Kim
-
Seoul, Korea, Republic of
- Not yet recruiting
- The Catholic University of Korea Seoul St.Mary's Hospital
-
Contact:
- Dong-Won Yang, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
<Screening Inclusion Criteria>
- 50 ≤ Age ≤ 85 at time of screening
- Diagnosed as a probable Alzheimer Dementia patient according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria
- 10 ≤ K-MMSE-2 score ≤ 26 at time of screening
- 0.5 ≤ CDR score ≤ 2 at time of screening
- Administration of donepezil 5 mg or 10 mg without dose change for at least 3 months at time of screening
- Ability to walk or to move using a walking aid (i.e. senior walker, cane, or wheelchair)
Presence of a caregiver who regularly spends time with the patient and can accompany the patient to hospital visits
- The caregiver must spend at least 8 hours per week with the patient
- The caregiver should be able to supervise trial compliance and report subject status to the investigator
- Sufficient visual acuity, hearing, language ability, motor function and comprehension, as judged by the investigator, to follow the examination procedure (auxiliary devices such as glasses and hearing aids are permitted)
- Voluntarily decision to participate in this clinical trial from both the subject and the subject's legal representative
<Randomization Inclusion Criteria>
- 10 ≤ K-MMSE-2 score ≤ 26 at time of randomization
- Compliance with donepezil ≥ 80% during run-in
Exclusion Criteria:
<Screening Exclusion Criteria>
Dementia due to other causes including:
- Probable vascular dementia according to NINDS-AIREN criteria
- Infection of the central nervous system (eg HIV, syphilis, etc.)
- Head trauma
- Creutzfeld-Jacob disease
- Pixie's disease
- Huntington's disease
- Parkinson's disease
- Drug addiction and/or Alcoholism
- Patients with other major structural brain diseases (strategic cerebral infarction, subdural hematoma, traffic hydrocephalus, brain tumor) and/or evidence (CT or MRI results performed within the past 12 months or at screening) as the cause of dementia (provided that (Excluding lacunar cerebral infarction with a diameter of less than 1 cm in the area judged not to be related to cognitive function)
- 3 ≤ New Rating Scale for ARWMC (Age-Related White Matter Changes) score within 12 months of screening
- Myocardial infarction, unstable angina pectoris, orthostatic hypotension or unexplained syncope within 12 months of screening, hospitalization for arrhythmia, or moderate to severe congestive heart failure (NYHA class III or IV), clinically Patients with significant structural heart disease (valvular disease, hypertrophic cardiomyopathy)
- Serious mental disorders such as severe depression, schizophrenia, alcoholism, and drug dependence
History of malignant tumor within 5 years of screening. (However, enrollment is allowed if any of the following applies:)
- More than 5 years since completion of treatment for tumor
- Basal cell carcinoma, squamous cell carcinoma of the skin, or prostate cancer
- Genetic problems such as galactose intolerance, lapp lactase deficiency or glucose galactose malabsorption
- Gastrointestinal diseases (inflammatory bowel disease, etc.) that may affect the absorption of clinical investigational drugs
- Administration of other dementia treatments (galantamine, rivastigmine, memantine) than donepezil within 3 months of screening
- Administration of brain function improving drugs (citicoline, oxiracetam, piracetam, choline alfoscerate, Nicergoline, Nimodipine, ginko-biloba, acetyl-l carnitine, etc.) within 1 month of screening
- Administration of dementia treatments, brain function improving agents, central nervous system stimulants, anticholinergics, tricyclic antidepressants, classic antipsychotics, and hypnotics (excluding short-acting hypnotics) other than experimental drugs during trial period
Administration of atypical antipsychotics, anxiolytics, antidepressants (except tricyclic antidepressants), thyroid hormones, short-acting hypnotics, hormone replacement therapy, vitamin E, vitamin B12 supplements, antiparkinsonian drugs, and cholinergic drugs during trial period (However, enrollment is allowed if all of the following apply:)
- Administration without any changes in dosage within 2 months of randomization
- Administration without any changes in dosage during trial period
- except for PRN drugs
- Hypersensitivity to clinical investigational drugs (choline alfoscerate, donepezil), its components, or piperidine derivatives
- Possibility of dementia due to abnormalities in vitamin B12, folic acid, and thyroid stimulating hormone (TSH) levels
Abnormalities in blood tests at screening:
- Liver dysfunction: AST or ALT ≥ 3 times the upper limit of normal range
- Renal dysfunction: Creatinine clearance* < 25 mL/min/1.73 m2
*MDRD Formula Creatinine clearance (mL/min/1.73m2)= 175 × {serum Creatinine (mg/dL)}- 1.154 × (Age)-0.203 × 0.742 (for female only)
- Uncontrolled hypertension (SBP>180 mmHg)
- Illitera
- Pregnancy and lactation
In case of a woman, a patient who does not fall under any of the following:
- Menopause for at least 2 years at time of screening
- Contraceptive through surgical methods
- Deemed inappropriate for enrollment by the investigator for other reasons <Randomization Exclusion Criteria>
1) Abnormalities in blood tests at time of randomization
- Liver dysfunction: AST or ALT ≥ 3 times the upper limit of normal range
- Renal dysfunction: Creatinine clearance* < 25 mL/min/1.73 m2 *MDRD Formula Creatinine clearance (mL/min/1.73m2)= 175 × {serum Creatinine (mg/dL)}- 1.154 × (Age)-0.203 × 0.742 (for female only) 2) Uncontrolled hypertension (SBP>180 mmHg) at the time of randomization 3) Administration of other investigational drugs within the past 3 months from the time of randomization 4) Deemed inappropriate for enrollment by the investigator for other reasons
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Choline Alfoscerate 1,200mg + Donepezil 5mg or 10mg
Oral administration of choline alfoscerate 400mg TID, donepezil QD (evening) for 48 weeks, no dosage change during trial period
|
Oral administration
|
Placebo Comparator: Placebo + Donepezil 5mg or 10mg
Oral administration of placebo TID, donepezil QD (evening) for 48 weeks, no dosage change during trial period
|
Oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in ADAS-Cog scores
Time Frame: 48 weeks from baseline
|
ADAS-cog change at 12 and 24 weeks from baseline Changes in ADAS-Cog scores at 48 weeks from baseline |
48 weeks from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in ADAS-Cog scores
Time Frame: Time Frame: 12, 24 weeks from baseline
|
Changes in ADAS-Cog scores at 12, 24 weeks from baseline
|
Time Frame: 12, 24 weeks from baseline
|
Changes in ADCOMS scores
Time Frame: 12, 24, and 48 weeks from baseline
|
Changes in ADCOMS scores at 12, 24 and 48 weeks from baseline
|
12, 24, and 48 weeks from baseline
|
Changes in K-IADL scores
Time Frame: 12, 24, and 48 weeks from baseline
|
Changes in K-IADL scores at 12, 24 and 48 weeks from baseline
|
12, 24, and 48 weeks from baseline
|
Changes in CDR-SB scores
Time Frame: 12, 24, and 48 weeks from baseline
|
Changes in CDR-SB scores at 12, 24 and 48 weeks from baseline
|
12, 24, and 48 weeks from baseline
|
Changes in K-MMSE-2 scores
Time Frame: 12, 24, and 48 weeks from baseline
|
Changes in K-MMSE-2 scores at 12, 24 and 48 weeks from baseline
|
12, 24, and 48 weeks from baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Gastrointestinal Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Nootropic Agents
- Lipotropic Agents
- Choline
Other Study ID Numbers
- DWB-CA400
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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