Alzheimer's DiseasePhase 4ALFO-ADNCT03441516
Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia
A Phase 4 study testing Alfoatirin® Tab. + Aripezil® Tab. and Aripezil® Tab. in people with Alzheimer's Disease, run by Yuhan Corporation at 6 sites in South Korea.
Trial summary
This study will evaluate the performance of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) in patients with Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Alfoatirin® Tab. + Aripezil® Tab. and Aripezil® Tab.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 19 Apr 2018to 31 Dec 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 - 90 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Dong-A University Hospital
Busan
Gyeongsang National University Hospital
Busan
Inje University Busan Paik Hospital
Busan
Inje University Haeundae Paik Hospital
Busan
Pusan National University Yangsan Hospital
Busan
Samsung Changwon Hospital
Busan
About this study
Official title: Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia: A Multi-center, Randomized, Open-label, Pilot Study
This study will evaluate the performance of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) in patients with Alzheimer's disease (AD).
- Conditions
- Alzheimer's Disease
- Being tested
- Alfoatirin® Tab. + Aripezil® Tab., Aripezil® Tab.
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfoatirin® Tab. + Aripezil® Tab.Drug
Choline Alphoscerate 400 mg Oral Tablet bid + Donepezil 10 mg Oral Tablet qd for 24 weeks
Aripezil® Tab.Drug
Donepezil 10 mg Oral Tablet qd for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Alfoatirin® Tab. + Aripezil® Tab. | Experimental | Choline Alphoscerate 400mg bid + Donepezil 10mg qd for 24 weeks Receives: Drug: Alfoatirin® Tab. + Aripezil® Tab. |
| Aripezil® Tab. | Active comparator | Donepezil 10mg qd for 24 weeks Receives: Drug: Aripezil® Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-cog
To evaluate cognitive function
Measured: At 24 weeks
Secondary outcomes (6)
ADAS-cog
To evaluate cognitive function
Measured: At 12 weeks
K-MMSE (Korean version of Mini-Mental State Examination)
To evaluate cognitive function
Measured: At 12 and 24 weeks
FAB (Frontal Assessment Battery)
To evaluate frontal lobe dysfunction
Measured: At 12 and 24 weeks
S-IADL (Seoul-Instrumental Activities of Daily Living)
To evaluate daily activities of living
Measured: At 12 and 24 weeks
CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory)
To evaluate neuropsychiatric symptom in dementia
Measured: At 12 and 24 weeks
Changes in brain metabolism by F-18 FDG brain PET
Measured: At 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start19 Apr 2018
- Primary completion4 Jul 2019
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441516
- Sponsor's protocol ID
- YMC034
- Acronym
- ALFO-AD
- Status last verified
- Dec 2020
- First submitted
- 5 Feb 2018
- Last updated
- 22 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia: A Multi-center, Randomized, Open-label, Pilot Study
- ClinicalTrials.gov ID
- NCT03441516
- Acronym / sponsor ID
- ALFO-AD / YMC034
- Conditions
- Alzheimer's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the performance of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) in patients with Alzheimer's disease (AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alfoatirin® Tab. + Aripezil® Tab. | Experimental | Drug: Alfoatirin® Tab. + Aripezil® Tab.Choline Alphoscerate 400mg bid + Donepezil 10mg qd for 24 weeks |
| Aripezil® Tab. | Active comparator | Drug: Aripezil® Tab.Donepezil 10mg qd for 24 weeks |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 50 - 90 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alfoatirin® Tab. + Aripezil® Tab.Choline Alphoscerate 400 mg Oral Tablet bid + Donepezil 10 mg Oral Tablet qd for 24 weeks | Drug | Alfoatirin® Tab. + Aripezil® Tab. |
| Aripezil® Tab.Donepezil 10 mg Oral Tablet qd for 24 weeks | Drug | Aripezil® Tab. |
Primary outcome
ADAS-cog
Time frame: At 24 weeks
To evaluate cognitive function
6 secondary outcomes
ADAS-cog
Time frame: At 12 weeks
K-MMSE (Korean version of Mini-Mental State Examination)
Time frame: At 12 and 24 weeks
FAB (Frontal Assessment Battery)
Time frame: At 12 and 24 weeks
S-IADL (Seoul-Instrumental Activities of Daily Living)
Time frame: At 12 and 24 weeks
CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory)
Time frame: At 12 and 24 weeks
Changes in brain metabolism by F-18 FDG brain PET
Time frame: At 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfoatirin® Tab. + Aripezil® Tab. and Aripezil® Tab. in people with Alzheimer's Disease, run by Yuhan Corporation at 6 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 6 inclusion and 5 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-cog (time frame: At 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2020.