Safety and Efficacy of MT-4666

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: MT-4666; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764243

P211-03

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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450 participants in 3 patient groups, including a placebo group

MT-4666 Low Dose

Experimental group

Description:

low dose

Treatment:

Drug: MT-4666

MT-4666 High Dose

Experimental group

Description:

high dose

Treatment:

Drug: MT-4666

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo