Alzheimer's Disease
Conditions
Keywords
Alzheimer's Disease, Nicotinic Acetylcholine Receptor Agonist, Cognitive function, Dementia, Central Nervous System Agents
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.
Interventions
DRUGMT-4666
low dose, high dose
DRUGPlacebo
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in ADAS-cog-13 | Baseline and Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| 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 Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) | Baseline and Week 24 |
| Change from baseline in Neuropsychiatric Inventory (NPI) | Baseline and Week 24 |
| Change from baseline in Modified Crichton Scale | Baseline and Week 24 |
| Change from baseline in Mini-Mental State Examination (MMSE) | Baseline and Week 24 |
Countries
Japan
Outcome results
None listed