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

Phase 3

• Conditions: Moderate to severe Alzheimer's disease

• Registration Number: JPRN-jRCT2080223154
• Lead Sponsor: DAIICHI SANKYO CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 204

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified