Safety and Efficacy of MT-4666
This study is currently recruiting participants.
Verified January 2013 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01764243
First received: December 26, 2012
Last updated: January 7, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: MT-4666 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo-Controlled Phase2 Study of MT-4666 in Patients With Mild to Moderate Probable Alzheimer's Disease. |
Resource links provided by NLM:
Further study details as provided by Mitsubishi Tanabe Pharma Corporation:
Primary Outcome Measures:
- Change from baseline in ADAS-cog-13 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change from baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change from baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change from baseline in Modified Crichton Scale [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 450 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MT-4666 Low Dose
low dose
|
Drug: MT-4666
low dose, high dose
|
|
Experimental: MT-4666 High Dose
high dose
|
Drug: MT-4666
low dose, high dose
|
|
Placebo Comparator: Placebo
placebo
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764243
Contacts
| Contact: Clinical Trials Information Desk | cti-inq-ml@ml.mt-pharma.co.jp |
Locations
| Japan | |
| Recruiting | |
| Kanto, Japan | |
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
| Study Director: | Yu Nakamura, M.D., Ph.D. | Kagawa University School of Medicine |
| Study Director: | Akira Homma, M.D. | Tokyo Dementia Care Research and Training Center |
| Study Director: | Shun Shimohama, M.D., D. Med. SC | Sapporo Medical University |
More Information
No publications provided
| Responsible Party: | Mitsubishi Tanabe Pharma Corporation |
| ClinicalTrials.gov Identifier: | NCT01764243 History of Changes |
| Other Study ID Numbers: | P211-03 |
| Study First Received: | December 26, 2012 |
| Last Updated: | January 7, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
|
Alzheimer's Disease Nicotinic Acetylcholine Receptor Agonist Cognitive function Dementia Central Nervous System Agents |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Central Nervous System Agents Nicotinic Agonists Therapeutic Uses Pharmacologic Actions Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013