Clinical trial NCT01764243: Safety and Efficacy of MT-4666
Official title: A Double-Blind, Placebo-Controlled Phase2 Study of MT-4666 in Patients With Mild to Moderate Probable Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Nicotinic Acetylcholine Receptor Agonist
Cognitive function
Dementia
Central Nervous System Agents
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2013-01-09
Enrollment: 450
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in ADAS-cog-13
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
timeFrame: Baseline and Week 24
measure: Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
timeFrame: Baseline and Week 24
measure: Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11)
timeFrame: Baseline and Week 24
measure: Change from baseline in Mini-Mental State Examination (MMSE)
timeFrame: Baseline and Week 24
measure: Change from baseline in Neuropsychiatric Inventory (NPI)
timeFrame: Baseline and Week 24
measure: Change from baseline in Modified Crichton Scale
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Kanto
country: Japan
Study officials:
affiliation: Kagawa University School of Medicine
name: Yu Nakamura, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Tokyo Dementia Care Research and Training Center
name: Akira Homma, M.D.
role: STUDY_DIRECTOR
affiliation: Sapporo Medical University
name: Shun Shimohama, M.D., D. Med. SC
role: STUDY_DIRECTOR
References: