Alzheimer's DiseasePhase 3NCT01249196
A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
A Phase 3 study testing SK-PC-B70M in people with Alzheimer's Disease, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- SK-PC-B70M
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Aug 2013
- Phase
- Phase 3
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of probable Alzheimer's disease(DSM-IV and NINCDS-ADRDA criteria)
- MRI within the last 12 months consistent with a diagnosis of AD
- MMSE score of 10 to 26 and CDR of 1 or 2
- AChEI or memantine was not taken at least 3 months prior to screening
Who cannot join
- Other central nervous disease
- Hypothyroidism, Vitamin B12/ Folic acid deficiency, Hypercalcemia, Neurosyphilis, AIDS
- T.I.A or Major infarction within the last 12 months
- Any serious disorder that could limit the ability of the patient to participate in the study
- COPD or asthma
- Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- SK-PC-B70M
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK-PC-B70MDrug
for dosage
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: SK-PC-B70M |
| SK-PC-B70M 200mg bid | Experimental | Not described Receives: Drug: SK-PC-B70M |
| SK-PC-B70M 300mg bid | Experimental | Not described Receives: Drug: SK-PC-B70M |
| Donepezil | Other | Not described Receives: Drug: SK-PC-B70M |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)
Measured: 30 minutes
Secondary outcomes (3)
CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input)
Measured: 45 minutes
MMSE (Mini Mental State Examination)
Measured: 10 minutes
CDR-SB (Clinical Dementia Rating Sum of Box)
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2013
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249196
- Sponsor's protocol ID
- SMART_AD_III_2009
- Status last verified
- Nov 2010
- First submitted
- 23 Nov 2010
- Last updated
- 26 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01249196
- Acronym / sponsor ID
- SMART_AD_III_2009
- Conditions
- Alzheimer's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2013 (actual)
- First posted
- 29 Nov 2010 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SK-PC-B70M |
| SK-PC-B70M 200mg bid | Experimental | Drug: SK-PC-B70M |
| SK-PC-B70M 300mg bid | Experimental | Drug: SK-PC-B70M |
| Donepezil | Other | Drug: SK-PC-B70M |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of probable Alzheimer's disease(DSM-IV and NINCDS-ADRDA criteria)
- MRI within the last 12 months consistent with a diagnosis of AD
- MMSE score of 10 to 26 and CDR of 1 or 2
- AChEI or memantine was not taken at least 3 months prior to screening
Key exclusion criteria (6 listed)
- Other central nervous disease
- Hypothyroidism, Vitamin B12/ Folic acid deficiency, Hypercalcemia, Neurosyphilis, AIDS
- T.I.A or Major infarction within the last 12 months
- Any serious disorder that could limit the ability of the patient to participate in the study
- COPD or asthma
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 |
|---|---|---|
| SK-PC-B70Mfor dosage | Drug | Donepezil, Placebo, SK-PC-B70M 200mg bid, SK-PC-B70M 300mg bid |
Primary outcome
ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)
Time frame: 30 minutes
3 secondary outcomes
CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input)
Time frame: 45 minutes
MMSE (Mini Mental State Examination)
Time frame: 10 minutes
CDR-SB (Clinical Dementia Rating Sum of Box)
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SK-PC-B70M in people with Alzheimer's Disease, run by SK Chemicals Co., Ltd. at 1 site 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (Alzheimer's Disease Assessment Scale-cognitive subscale) (time frame: 30 minutes). 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 26 Nov 2013.