Alzheimer's DiseasePhase 2NCT01764243
Safety and Efficacy of MT-4666
A Phase 2 study testing MT-4666 in people with Alzheimer's Disease, run by Tanabe Pharma Corporation at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the safety and efficacy as assessed by the Alzheimers Disease Assessment Scale-cognitive subscale 13-item (ADAS-cog-13) of two doses of MT-4666 or placebo administered daily for 24 weeks to subjects with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- MT-4666
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2012to Jul 2015
- Phase
- Phase 2
- 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
- Probable Alzheimer's disease consistent with National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA) criteria
- MMSE score of 10 to 24 inclusive at screening and at Day 1, and CDR-SB score of ≥ 2 at screening
- Modified Hachinski Ischemic Score (mHIS) ≤ 4 at screening
- Caregiver available; caregiver sees subject at least four days (at least 12 hours) each week
- Subject living at home; if living at senior residential setting, or an institutional setting, subject with caregiver indicated above is available
Who cannot join
- Inability to perform cognitive tests (ADAS-cog-13 and MMSE) at screening and at Day 1
- Diagnosis of any other disease which may cause dementia
- MRI or CT scan within 6 months before screening, with findings inconsistent with the diagnosis of Probable AD
- Diagnosis of major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) within last five years
- History of or current diagnosis of any psychosis
- History of myocardial infarction or unstable angina within six months before screening
- History of cerebrovascular disorder within 18 months before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Phase2 Study of MT-4666 in Patients With Mild to Moderate Probable Alzheimer's Disease.
The objective of this study is to evaluate the safety and efficacy as assessed by the Alzheimers Disease Assessment Scale-cognitive subscale 13-item (ADAS-cog-13) of two doses of MT-4666 or placebo administered daily for 24 weeks to subjects with mild to moderate Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- MT-4666, Placebo
- Keywords
- Alzheimer's Disease, Nicotinic Acetylcholine Receptor Agonist, Cognitive function, Dementia, Central Nervous System Agents
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-4666Drug
low dose, high dose
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| MT-4666 Low Dose | Experimental | low dose Receives: Drug: MT-4666 |
| MT-4666 High Dose | Experimental | high dose Receives: Drug: MT-4666 |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in ADAS-cog-13
Measured: Baseline and Week 24
Secondary outcomes (6)
Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Measured: Baseline and Week 24
Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Measured: Baseline and Week 24
Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11)
Measured: Baseline and Week 24
Change from baseline in Mini-Mental State Examination (MMSE)
Measured: Baseline and Week 24
Change from baseline in Neuropsychiatric Inventory (NPI)
Measured: Baseline and Week 24
Change from baseline in Modified Crichton Scale
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionJul 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Nakamura, M.D., Ph.D., Study director, Kagawa University School of MedicineAkira Homma, M.D., Study director, Tokyo Dementia Care Research and Training CenterShun Shimohama, M.D., D. Med. SC, Study director, Sapporo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764243
- Sponsor's protocol ID
- P211-03
- Status last verified
- Sep 2015
- First submitted
- 26 Dec 2012
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Phase2 Study of MT-4666 in Patients With Mild to Moderate Probable Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT01764243
- Acronym / sponsor ID
- P211-03
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Nicotinic Acetylcholine Receptor Agonist, Cognitive function, Dementia, Central Nervous System Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 Jan 2013 (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 objective of this study is to evaluate the safety and efficacy as assessed by the Alzheimers Disease Assessment Scale-cognitive subscale 13-item (ADAS-cog-13) of two doses of MT-4666 or placebo administered daily for 24 weeks to subjects 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
- 3
| Arm | Type | Receives |
|---|---|---|
| MT-4666 Low Dose | Experimental | Drug: MT-4666low dose |
| MT-4666 High Dose | Experimental | Drug: MT-4666high dose |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Probable Alzheimer's disease consistent with National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA) criteria
- MMSE score of 10 to 24 inclusive at screening and at Day 1, and CDR-SB score of ≥ 2 at screening
- Modified Hachinski Ischemic Score (mHIS) ≤ 4 at screening
- Caregiver available; caregiver sees subject at least four days (at least 12 hours) each week
- Subject living at home; if living at senior residential setting, or an institutional setting, subject with caregiver indicated above is available
Key exclusion criteria (7 listed)
- Inability to perform cognitive tests (ADAS-cog-13 and MMSE) at screening and at Day 1
- Diagnosis of any other disease which may cause dementia
- MRI or CT scan within 6 months before screening, with findings inconsistent with the diagnosis of Probable AD
- Diagnosis of major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) within last five years
- History of or current diagnosis of any psychosis
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 |
|---|---|---|
| MT-4666low dose, high dose | Drug | MT-4666 High Dose, MT-4666 Low Dose |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in ADAS-cog-13
Time frame: Baseline and Week 24
6 secondary outcomes
Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Time frame: Baseline and Week 24
Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Time frame: Baseline and Week 24
Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11)
Time frame: Baseline and Week 24
Change from baseline in Mini-Mental State Examination (MMSE)
Time frame: Baseline and Week 24
Change from baseline in Neuropsychiatric Inventory (NPI)
Time frame: Baseline and Week 24
Change from baseline in Modified Crichton Scale
Time frame: Baseline and Week 24
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 28 Sep 2015.
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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.
Yu Nakamura, M.D., Ph.D. study director
Kagawa University School of Medicine
Akira Homma, M.D. study director
Tokyo Dementia Care Research and Training Center
Shun Shimohama, M.D., D. Med. SC study director
Sapporo Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT-4666 in people with Alzheimer's Disease, run by Tanabe Pharma Corporation at 1 site in Japan.
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 5 inclusion and 7 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 28 Sep 2015. 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 from baseline in ADAS-cog-13 (time frame: Baseline and Week 24). 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 28 Sep 2015; AzTrials last refreshed its copy on 6 Nov 2026.