Memantine Treatment in Alzheimer's Disease Patients

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03168997

Enrollment

222

Registered

2017-05-30

Start date

2017-07-15

Completion date

2018-12-31

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease Memantine

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.

Interventions

DRUGMemantine Hydrochloride

Memantine Hydrochloride treatment according to clinical routine treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026