Memantine Treatment in Alzheimer's Disease Patients

Wei Cuibai

Status and phase: Unknown; Phase 4

Conditions: Alzheimer Disease

Treatments: Drug: Memantine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03168997

17237T

Details and patient eligibility

About

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

Full description

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

Enrollment: 222 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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222 participants in 3 patient groups

Mild AD

Other group

Description:

Memantine Hydrochloride 20mg tablet per day by mouth on mild AD

Treatment:

Drug: Memantine Hydrochloride

Moderate AD

Other group

Description:

Memantine Hydrochloride 20mg tablet per day by mouth on moderate AD

Treatment:

Drug: Memantine Hydrochloride

Severe AD

Other group

Description:

Memantine Hydrochloride 20mg tablet per day by mouth on severe AD

Treatment:

Drug: Memantine Hydrochloride