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Alzheimer DiseasePhase 4COALANCT05383183

Efficacy and Safety of ChOline ALfoscerate in Patient With Mild to Moderate Alzheimer's Disease

A Phase 4 study testing Choline Alfoscerate 400mg in people with Alzheimer Disease, run by Daewoong Bio Inc. at 4 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether combination of donepezil, a cholinesterase inhibitor, with choline alfoscerate has a more favourable clinical profile than monotherapy with donepezil alone. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Choline Alfoscerate 400mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
630 participants
Where
4 sitesSouth Korea
Study dates
20 Jan 2022to 9 Dec 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • <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
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  • 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

Who cannot join

  • <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
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  • 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

Trial locations and contacts

4 sites in 1 country.

Yunjae Ahn contact

+82-550-8191

yjahn@daewoong-bio.co.kr

South Korea4 sites, 4 recruiting

  • Changwon Fatima Hospital

    Changwon

    Jay-Cheol Kwon

    Recruiting

  • Gachon University Gil Medical Center

    Incheon

    Ki Hyung Park

    Recruiting

  • CHA Bundang Medical Center

    Seongnam

    Hyun Sook Kim

    Recruiting

  • The Catholic University of Korea Seoul ST.MARY'S Hospital

    Seoul

    Dong-Won Yang, MD, PhD

    Not yet recruiting

Other trials in South Korea

About this study

Official title: 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

The purpose of this study is to determine whether combination of donepezil, a cholinesterase inhibitor, with choline alfoscerate has a more favourable clinical profile than monotherapy with donepezil alone.

Read the detailed description

Aging population is a characteristic feature of demographic trends in developed countries. Hence, Alzheimer's disease is recognized as one of today's major healthcare challanges, and its significance will increase even more as the longevity of the population increases. Pre-clinical investigations have suggested that association between ChE-Is (cholinesterase inhibitors) and the cholinergic precursor choline alfoscerate enhances cholinergic neurotransmission more effectively than single compounds alone. This clinical trial is designed to assess if combination of the ChE-I donepezil with choline alfoscerate has a more favorable clinical profile than monotherapy with donepezil alone.

Being tested
Choline Alfoscerate 400mg, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Choline Alfoscerate 400mgDrug

    Oral administration

  • PlaceboDrug

    Oral administration

Study groups in NCT05383183
Study groupRoleWhat they receive
Choline Alfoscerate 1,200mg + Donepezil 5mg or 10mgExperimentalOral administration of choline alfoscerate 400mg TID, donepezil QD (evening) for 48 weeks, no dosage change during trial period
Receives: Drug: Choline Alfoscerate 400mg
Placebo + Donepezil 5mg or 10mgPlacebo comparatorOral administration of placebo TID, donepezil QD (evening) for 48 weeks, no dosage change during trial period
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in ADAS-Cog scores

    ADAS-cog change at 12 and 24 weeks from baseline

    Changes in ADAS-Cog scores at 48 weeks from baseline

    Measured: 48 weeks from baseline

Secondary outcomes (5)

  1. Changes in ADAS-Cog scores

    Changes in ADAS-Cog scores at 12, 24 weeks from baseline

    Measured: Time Frame: 12, 24 weeks from baseline

  2. Changes in ADCOMS scores

    Changes in ADCOMS scores at 12, 24 and 48 weeks from baseline

    Measured: 12, 24, and 48 weeks from baseline

  3. Changes in K-IADL scores

    Changes in K-IADL scores at 12, 24 and 48 weeks from baseline

    Measured: 12, 24, and 48 weeks from baseline

  4. Changes in CDR-SB scores

    Changes in CDR-SB scores at 12, 24 and 48 weeks from baseline

    Measured: 12, 24, and 48 weeks from baseline

  5. Changes in K-MMSE-2 scores

    Changes in K-MMSE-2 scores at 12, 24 and 48 weeks from baseline

    Measured: 12, 24, and 48 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2022
  2. Study start20 Jan 2022
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion9 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
630 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05383183
Sponsor's protocol ID
DWB-CA400
Acronym
COALA
Status last verified
Mar 2024
First submitted
6 Dec 2021
Last updated
21 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Choline Alfoscerate 400mg in people with Alzheimer Disease, run by Daewoong Bio Inc. at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yunjae Ahn (+82-550-8191, yjahn@daewoong-bio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in ADAS-Cog scores (time frame: 48 weeks from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05383183.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.

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