Memantine Treatment in Alzheimer's Disease Patients

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

Official Title
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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

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: Memantine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mild AD<br>Memantine Hydrochloride 20mg tablet per day by mouth on mild AD | Drug: Memantine Hydrochloride<br>* Memantine Hydrochloride treatment according to clinical routine treatment<br>* Other names: Memantine;|
| Other: Moderate AD<br>Memantine Hydrochloride 20mg tablet per day by mouth on moderate AD | Drug: Memantine Hydrochloride<br>* Memantine Hydrochloride treatment according to clinical routine treatment<br>* Other names: Memantine;|
| Other: Severe AD<br>Memantine Hydrochloride 20mg tablet per day by mouth on severe AD | Drug: Memantine Hydrochloride<br>* Memantine Hydrochloride treatment according to clinical routine treatment<br>* Other names: Memantine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-cog change | Alzheimer's Disease Co-operative Study Alzheimer's Disease Assessment Scale - cognitive section is the cognitive evaluation scale | ADAD-cog Change from baseline to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer Disease Memantine