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Safety and Efficacy of MT-4666 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy of MT-4666

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

NCT01764243•Tanabe Pharma Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Kanto, Japan

Key Dates

Start Date

November 1, 2012

Primary Completion Date

June 1, 2015

Completion Date

July 1, 2015

Last Updated

September 28, 2015

Enrollment

450

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

MT-4666

DRUG

Placebo

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

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Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of MT-4666

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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