Memantine Treatment in Alzheimer's Disease Patients Stratified With Behavioral and Psychological Symptoms of Dementia (BPSD) Symptoms and Cognitive Severity: A Multi-center, Open-label, Parallel-group and Prospective Clinical Study

Wei Cuibai0 sites222 target enrollmentJuly 15, 2017

ConditionsAlzheimer Disease

InterventionsMemantine Hydrochloride

DrugsMemantine Hydrochloride

Overview

Phase: Phase 4
Intervention: Memantine Hydrochloride
Conditions: Alzheimer Disease
Sponsor: Wei Cuibai
Enrollment: 222
Primary Endpoint: ADAS-cog change
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The aim of this study is to investigate whether there will be any efficacy difference of Memantine treatment in different cognitive severity AD patients stratified with BPSD

Detailed Description

Planed to enroll a total of 222 patients with mild, moderate or severe AD treated with Memantine in 2017-2018 from 15 centers.

Registry

clinicaltrials.gov

Start Date

July 15, 2017

End Date

December 31, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wei Cuibai

Responsible Party

Sponsor Investigator

Principal Investigator

Wei Cuibai

Professor, MD, PhD.

Xuanwu Hospital, Beijing

Eligibility Criteria

Inclusion Criteria

•Probable AD based on the diagnosis criteria of NIA-AA guideline (the U.S. National Institute on Aging and Alzheimer's Association guideline, McKhann et al, 2011\[8\];
•Male or female, 50 years and older ;
•All inpatients or outpatients recruited into this study must meet MMSE score ≤24 points, patients with MMSE score as 21-24 points will be enrolled into mild group, patients with MMSE score as 10-20 points will be enrolled into moderate group, patients with MMSE score less than 10 points will be enrolled into severe group.
•Have a reliable caregiver who can accompany the patient to the site to complete the required study procedures;
•Provide the informed consent.

Exclusion Criteria

•Patients with disturbance of consciousness of any causes;
•Patients with severe aphasia or physical disability who were unable to complete neuropsychological examination;
•Patients with mental illness;
•Patients with a history of alcoholism and drug addiction, or traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus and other neurological disorders causing cognitive impairment;
•Patients with systemic diseases causing dementia (e.g. liver and kidney insufficiency, endocrine disorders, vitamin deficiency);
•Patients with a history of ischemic or hemorrhagic cerebrovascular diseases, and vascular diseases (stroke foci) as confirmed by imaging examination;
•Subjects who are unwilling or unable to abide by the study requirement.