Safety and Efficacy of MT-4666

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Placebo-Controlled Phase2 Study of MT-4666 in Patients With Mild to Moderate Probable Alzheimer's Disease.

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: MT-4666
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-4666 Low Dose<br>low dose | Drug: MT-4666<br>* low dose, high dose<br>|
| Experimental: MT-4666 High Dose<br>high dose | Drug: MT-4666<br>* low dose, high dose<br>|
| Placebo Comparator: Placebo<br>placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in ADAS-cog-13 |  | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) |  | Baseline and Week 24 | 
| Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) |  | Baseline and Week 24 | 
| Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11) |  | Baseline and Week 24 | 
| Change from baseline in Mini-Mental State Examination (MMSE) |  | Baseline and Week 24 | 
| Change from baseline in Neuropsychiatric Inventory (NPI) |  | Baseline and Week 24 | 
| Change from baseline in Modified Crichton Scale |  | Baseline and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's Disease, Nicotinic Acetylcholine Receptor Agonist, Cognitive function, Dementia, Central Nervous System Agents