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
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 222
- Primary Endpoint
- ADAS-cog change
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mild AD
Memantine Hydrochloride 20mg tablet per day by mouth on mild AD
Intervention: Memantine Hydrochloride (Drug)
Moderate AD
Memantine Hydrochloride 20mg tablet per day by mouth on moderate AD
Intervention: Memantine Hydrochloride (Drug)
Severe AD
Memantine Hydrochloride 20mg tablet per day by mouth on severe AD
Intervention: Memantine Hydrochloride (Drug)
Outcomes
Primary Outcomes
ADAS-cog change
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Wei Cuibai
Professor, MD, PhD.
Xuanwu Hospital, Beijing