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

NCT02327182 | Terminated Phase 3

• 1 other identifier: P211-05
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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).

Conditions

Alzheimer's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Mini Mental State Examination (MMSE)

  baseline to Week 52

• Change in Neuropsychiatric Inventory (NPI) total score

  baseline to Week 52

Study Arms (2)

MT-4666 low dose

EXPERIMENTAL

Low Dose, Tablet, Once Daily, For 52 Weeks

Drug: MT-4666

MT-4666 high dose

EXPERIMENTAL

High Dose, Tablet, Once Daily, For 52 Weeks

Drug: MT-4666

Interventions

MT-4666 DRUG

MT-4666 high dose; MT-4666 low dose

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational site

Osaka, Kansai, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yu Nakamura, M.D., Ph.D.

  Kagawa University School of Medicine

  STUDY DIRECTOR

• Kazuoki Kondo, M.D.

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 30, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

JP (1)