Phase III clinical study of SUN Y7017 Double blind controlled Study for safety evaluation of 1-step titration with 3-step titration in patients with moderate to severe Alzheimer's disease
Phase III clinical study of SUN Y7017 Safety evaluation of 1-step titration with 3-step titration in patients with moderate to severe Alzheimer's disease
version:
date:
DAIICHI SANKYO Co.,Ltd.
dsclinicaltrial@daiichisankyo.co.jp
204
Interventional
Multicenter, Randomized, Double-blind
3
1. Patients with a diagnosis of dementia of the Alzheimer's type based on DSM-IV-TR and probable Alzheimer's disease according to the NINCDS-ADRDA diagnostic criteria.
2. Patients with a diagnosis of AD based on brain computed tomography (CT) or magnetic resonance imaging (MRI) within 1 year prior to randomization
3. Patients with an MMSE score from 1 to 19 at enrollment
4. Patients aged between 50 and 85 years when consent is obtained.
5. Patients who are ambulatory without walking aids or with a modest aid such as a walking stick. Patients are also required to have good enough eyesight and hearing to undergo the tests and examinations scheduled in the study (eye glasses or hearing aids can be used)
6. Patients whose caregivers are cooperative and reliable enough to manage the study drug, attend study visits with the patient, and check the patient's clinical condition throughout the study period. Patients who will have the same caregiver, in principle, for every study visit throughout the study
1. Patients with other type of dementia that is not AD
2. Patients with Significant neurological disorders
3. Musculoskeletal diseases that may hamper conduct of the tests and examinations required in this study
4. Any of the following diseases or symptoms
1) diastolic pressure >=110 mmHg or systolic pressure <90 mmHg
2) Myocardial infarction within 6 months prior to the date of giving informed consent
3) Congestive heart failure (NYHA class III or IV )
4) Severe renal impairment
5) Severe hepatic impairment
6) Uncontrolled diabetes mellitus
7) Malignant tumor
5. A history of alcoholism or drug dependence
6. A history of hypersensitivity to any component of memantine hydrochloride
7. Planned change of the subject's living environment (admission to a nursing facility, moving house, etc.) during the study period
50age old over
85age old under
Both
Moderate to severe Alzheimer's disease
investigational material(s)
Generic name etc : SUN Y7017
INN of investigational material : memantine
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administration for Investigational material : The subject will orally take 3 tablets of placebo and memantine hydrochloride once daily during the titration period, and will take 1 tablet of memantine hydrochloride once daily during the maintenance period. The duration of study treatment is 24 weeks. Titration group A: Treatment will be started at 5 mg once daily, and the dose will be increased by 5 mg weekly up to the maintenance dose of 20 mg . Titration group B: Treatment will be started at 10 mg once daily, and the dose will be increased to the maintenance dose of 20 mg in Week 3
Adverse events leading to discontinuation of the study
The incidence of adverse events leading to discontinuation of the study
SIB-J, J-CGIC, MMSE
The change from baseline at week 24
