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UnknownPhase 4

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

Lead sponsor

Wei Cuibai

Asset

Memantine

Listed sites

0

Recruiting sites

-

Enrollment

222

estimated

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseMMSE ≤24Study partner/caregiver required

Primary endpoint

ADAS-Cog

Identifiers

Registered as

Org study ID17237T
NCT IDNCT03168997

Timeline

Milestones

Study first posted2017-05-30actual
Last update posted2017-05-30actual
Study start2017-07-15estimated
Primary completion2018-09-30estimated
Study completion2018-12-31estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

1 endpoint
Primary/protocol endpoint

ADAS-cog change

Time frame:ADAD-cog Change from baseline to 24 weeks

ADAS-Cog

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.