Safety Study of MT-4666 in Subjects With Alzheimer's Disease

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of MT-4666 administered once daily for 52 weeks with or without receiving a concomitant acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimer's Disease (AD).

Official Title
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A Long-Term Safety Study of MT-4666 in Patients With Mild to Moderate Alzheimer's Disease (AD)

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: MT-4666


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Probable Alzheimer's disease consistent with the National Institute on Aging and the Alzheimer's Association Criteria for Diagnosis of Alzheimer's Disease (McKhann et al. 2011). MMSE score of ≥ 14 and ≤ 24 at the screening and ≥ 12 and ≤ 26 at the baseline. Modified Hachinski Ischemic Score (mHIS) ≤ 4 at the screening Appropriate caregiver available Subject living at home or in facilities who do not require continuous (24-hour) nursing care. Exclusion Criteria: Diagnosis of any other disease which may cause dementia 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 complication of hepatic disorder or renal dysfunction

Ages Eligible for Study
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Minimum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-4666 low dose<br>Low Dose, Tablet, Once Daily, For 52 Weeks | Drug: MT-4666<br> <br> |
| Experimental: MT-4666 high dose<br>High Dose, Tablet, Once Daily, For 52 Weeks | Drug: MT-4666<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of 2 fixed doses of EVP-6124 in subjects with Alzheimer's disease. Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, Columbia Suicide Severity Rating Scale (C-SSRS) |  | Up to week 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mini Mental State Examination (MMSE) |  | baseline to Week 52 | 
| Change in Neuropsychiatric Inventory (NPI) total score |  | baseline to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MT-4666, α7 nicotinic acetylcholine receptor agonist, Alzheimer's Disease, Cognitive function, Dementia, Central Nervous System Agents