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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02327182

Enrollment

117

Registered

2014-12-30

Start date

2014-12-31

Completion date

2015-10-31

Last updated

2015-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

MT-4666, α7 nicotinic acetylcholine receptor agonist, Alzheimer's Disease, Cognitive function, Dementia, Central Nervous System Agents

Brief summary

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).

Interventions

DRUGMT-4666

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Change in Mini Mental State Examination (MMSE)	baseline to Week 52
Change in Neuropsychiatric Inventory (NPI) total score	baseline to Week 52

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026