Memantine Treatment in Alzheimer's Disease Patients

NCT ID: NCT03168997

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-15
• Study Completion Date: 2018-12-31

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mild AD

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

Group Type: OTHER

Memantine Hydrochloride

Intervention Type: DRUG

Memantine Hydrochloride treatment according to clinical routine treatment

Moderate AD

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

Group Type: OTHER

Memantine Hydrochloride

Intervention Type: DRUG

Memantine Hydrochloride treatment according to clinical routine treatment

Severe AD

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

Group Type: OTHER

Memantine Hydrochloride

Intervention Type: DRUG

Memantine Hydrochloride treatment according to clinical routine treatment

Interventions

Memantine Hydrochloride

Memantine Hydrochloride treatment according to clinical routine treatment

Intervention Type: DRUG

Other Intervention Names

Memantine

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wei Cuibai

OTHER

Sponsor Role: lead

Responsible Party

Wei Cuibai

Professor, MD, PhD.

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

17237T

Identifier Type: -

Identifier Source: org_study_id