NCT01764243

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

2.6 years

First QC Date

December 26, 2012

Last Update Submit

September 24, 2015

Conditions

Alzheimer's Disease

Keywords

Alzheimer's DiseaseNicotinic Acetylcholine Receptor AgonistCognitive functionDementiaCentral Nervous System Agents

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in ADAS-cog-13

    Baseline and Week 24

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

MT-4666 Low Dose

EXPERIMENTAL

low dose

Drug: MT-4666

MT-4666 High Dose

EXPERIMENTAL

high dose

Drug: MT-4666

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

MT-4666DRUG

low dose, high dose

MT-4666 High DoseMT-4666 Low Dose
PlaceboDRUG
Placebo

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kanto, Japan

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2012

First Posted

January 9, 2013

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

JP(1)