Memantine Treatment in Alzheimer's Disease Patients

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03168997
• Other study ID #: 17237T
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 16, 2017
• Last updated: May 25, 2017
• Start date: July 15, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2017
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 222
• Est. completion date: December 31, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Memantine Hydrochloride
Memantine Hydrochloride treatment according to clinical routine treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wei Cuibai

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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