Memantine Treatment in Alzheimer's Disease Patients

Phase 4

• Conditions: Alzheimer Disease
• Interventions: Drug: Memantine Hydrochloride

• Registration Number: NCT03168997
• Lead Sponsor: Wei Cuibai

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.

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-25
• Last Update Submitted: 2017-05-25
• Study First Posted: 2017-05-30
• Last Update Posted: 2017-05-30
• Study Start: 2017-07-15
• Primary Completion: 2018-09-30
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

1. 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];
2. Male or female, 50 years and older ;
3. 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.
4. Have a reliable caregiver who can accompany the patient to the site to complete the required study procedures;
5. Provide the informed consent.

Exclusion Criteria

1. Patients with disturbance of consciousness of any causes;
2. Patients with severe aphasia or physical disability who were unable to complete neuropsychological examination;
3. Patients with mental illness;
4. 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;
5. Patients with systemic diseases causing dementia (e.g. liver and kidney insufficiency, endocrine disorders, vitamin deficiency);
6. Patients with a history of ischemic or hemorrhagic cerebrovascular diseases, and vascular diseases (stroke foci) as confirmed by imaging examination;
7. Subjects who are unwilling or unable to abide by the study requirement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild AD	Memantine Hydrochloride	Memantine Hydrochloride 20mg tablet per day by mouth on mild AD
Moderate AD	Memantine Hydrochloride	Memantine Hydrochloride 20mg tablet per day by mouth on moderate AD
Severe AD	Memantine Hydrochloride	Memantine Hydrochloride 20mg tablet per day by mouth on severe AD

Primary Outcome Measures

Name	Time	Method
ADAS-cog change	ADAD-cog Change from baseline to 24 weeks	Alzheimer's Disease Co-operative Study Alzheimer's Disease Assessment Scale - cognitive section is the cognitive evaluation scale