Alzheimer Type DementiaPhase 3NCT01245530
An Efficacy and Safety Study of INM-176 for the Treatment of Patients With Alzheimer Type Dementia
A Phase 3 study testing Aricept and INM-176 in people with Alzheimer Type Dementia, run by Whanin Pharmaceutical Company at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of two fixed dose (1200mg/day, 1600mg/day) of INM-176 (a drug of treating dementia) comparing with donepezil for treatment for patients with Alzheimer type dementia. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Type Dementia
- What is being tested?
- Aricept and INM-176
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2008to Mar 2011
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age range : 50 ~ 80 years old
- Informed consent signed and dated by patient or legal representative
- Subjects diagnosed with Alzheimer's disease according to DSM-IV criteria
- Subjects diagnosed with probable Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- MMSE score 10 to 26
- CDR(Clinical Dementia Rating) score 1~2 or GDS(Global Deterioration Scale) 3~5 stage
- Subjects who didn't take any medication for AchEI (donepezil, memantine, galantamin, etc) before treating or can stop medication at least 4 weeks more prior to screening visit
- Subjects menopause women or her/his spouse consent with contraception during the study period and 90 days after end of study
Who cannot join
- Subjects with psychiatric disorders other than Alzheimer's disease, such as schizophrenia, depression, bipolar disorder, etc
- Subjects diagnosed or accompanied with Dementia due to other Neurodegenerative disorders (AIDS, syphilis, creutzfeldt-jacob disease, Picks Disease, Huntingtons Disease, Parkinsons disease related dementia)
- Subjects diagnosed with vascular dementia
- Subjects diagnosed with stroke within last 3 months prior to screening visit
- Subjects who have medical history of significant hepatic disease in screening visit (2 ULN≤ALT, AST)
- Subjects who have medical history of significant renal disease in screening visit (1.5mg/dl≤Serum creatinine)
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- Subjects who have difficult with regulating blood glucose level with anti-diabetes drug (8.0%<HbA1c)
- Subjects who have medical history of myocardial infarction or arrhythmia
- Subjects who take warfarin with Atrial fibrillation
- Pregnant or nursing women
- Subjects who p0articipated in other clinical trail within last 3 months
- Subjects who have hypersensitivity to AchEl (acetylcholinesterase inhibitor)
- Subjects who have unstable clinical laboratory result in screening visit
- Subjects doubted the pulmonary disease on the chest X-ray in screening visit
- Subjects considered unsuitable to participate in clinical trail by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probable Alzheimer Type Dementia Compare INM-176 1200~1600mg/Day With Donepezil 5~10mg/Day of Safety and Efficacy to Randomization, Multicenter, Double-blind, Double-dummy, Parallel Phase III Clinical Study
The purpose of this study is to evaluate the efficacy and safety of two fixed dose (1200mg/day, 1600mg/day) of INM-176 (a drug of treating dementia) comparing with donepezil for treatment for patients with Alzheimer type dementia.
Read the detailed description
Probable Alzheimer type dementia compare INM-176 1200~1600mg/day with Donepezil 5~10mg/day of safety and efficacy to randomization, multicenter, double-blind, double-dummy, parallel Phase III clinical study.
- Conditions
- Alzheimer Type Dementia
- Being tested
- Aricept, INM-176
- Keywords
- Alzheimer disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AriceptDrug
Also called Donepezil HCl
Aricept Comparator Intervention: Drug: Aricept 5~10 mg orally every day for 24weeks
INM-176Drug
Also called KR-WAP-026
INM-176: Experimental Intervention: Drug:INM-176 600~1200 mg orally every day for 24weeks
| Study group | Role | What they receive |
|---|---|---|
| Aricept | Active comparator | Intervention: Drug: Aricept Receives: Drug: Aricept |
| INM-176 | Experimental | Intervention: Drug: INM-176 Receives: Drug: INM-176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score
Measured: up to 24 weeks
Secondary outcomes (5)
Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
Measured: up to 24 weeks
Change from baseline to endpoint in Clinical Dementia Rating
Measured: up to 24 weeks
Change from baseline to endpoint in Global Deterioration Scale(GDS)
Measured: up to 24 weeks
Change from baseline to endpoint in Korean Activity of Living(K-IADL)
Measured: up to 24 weeks
Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI)
Measured: up to 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 Nov 2010 (estimated)
- Study startJun 2008
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Type DementiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Whanin Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- SangYoon Kim, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245530
- Sponsor's protocol ID
- INM-176
- Status last verified
- Jun 2011
- First submitted
- 1 Nov 2010
- Last updated
- 13 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probable Alzheimer Type Dementia Compare INM-176 1200~1600mg/Day With Donepezil 5~10mg/Day of Safety and Efficacy to Randomization, Multicenter, Double-blind, Double-dummy, Parallel Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT01245530
- Acronym / sponsor ID
- INM-176
- Conditions
- Alzheimer Type Dementia
- Keywords
- Alzheimer disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Whanin Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 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 two fixed dose (1200mg/day, 1600mg/day) of INM-176 (a drug of treating dementia) comparing with donepezil for treatment for patients with Alzheimer type dementia.
Detailed description
Probable Alzheimer type dementia compare INM-176 1200~1600mg/day with Donepezil 5~10mg/day of safety and efficacy to randomization, multicenter, double-blind, double-dummy, parallel Phase III clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aricept | Active comparator | Drug: AriceptIntervention: Drug: Aricept |
| INM-176 | Experimental | Drug: INM-176Intervention: Drug: INM-176 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, age range : 50 ~ 80 years old
- Informed consent signed and dated by patient or legal representative
- Subjects diagnosed with Alzheimer's disease according to DSM-IV criteria
- Subjects diagnosed with probable Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- MMSE score 10 to 26
Key exclusion criteria (15 listed)
- Subjects with psychiatric disorders other than Alzheimer's disease, such as schizophrenia, depression, bipolar disorder, etc
- Subjects diagnosed or accompanied with Dementia due to other Neurodegenerative disorders (AIDS, syphilis, creutzfeldt-jacob disease, Picks Disease, Huntingtons Disease, Parkinsons disease related dementia)
- Subjects diagnosed with vascular dementia
- Subjects diagnosed with stroke within last 3 months prior to screening visit
- Subjects who have medical history of significant hepatic disease in screening visit (2 ULN≤ALT, AST)
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 |
|---|---|---|
| AriceptAlso: Donepezil HClAricept Comparator Intervention: Drug: Aricept 5~10 mg orally every day for 24weeks | Drug | Aricept |
| INM-176Also: KR-WAP-026INM-176: Experimental Intervention: Drug:INM-176 600~1200 mg orally every day for 24weeks | Drug | INM-176 |
Primary outcome
Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score
Time frame: up to 24 weeks
5 secondary outcomes
Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
Time frame: up to 24 weeks
Change from baseline to endpoint in Clinical Dementia Rating
Time frame: up to 24 weeks
Change from baseline to endpoint in Global Deterioration Scale(GDS)
Time frame: up to 24 weeks
Change from baseline to endpoint in Korean Activity of Living(K-IADL)
Time frame: up to 24 weeks
Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI)
Time frame: up to 24 weeks
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 13 Jun 2011.
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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.
SangYoon Kim, MD principal investigator
Seoul National University Bundang Hospital
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 Aricept and INM-176 in people with Alzheimer Type Dementia, run by Whanin Pharmaceutical Company 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 8 inclusion and 15 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 13 Jun 2011. 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. 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?
Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score (time frame: up to 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 13 Jun 2011.