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Evaluation of the efficacy and safety of Memantine hydrochloride oral membranes in the treatment of moderate-to-severe and severe senile dementia patients in real-world settings: a multicenter registry study

Evaluation of the efficacy and safety of Memantine hydrochloride oral membranes in the treatment of moderate-to-severe and severe senile dementia patients in real-world settings: a multicenter registry study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071719
Enrollment
Unknown
Registered
2023-05-23
Start date
2023-05-27
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Senile dementia

Interventions

Observation group:N/A

Sponsors

The Second Hospital, Cheeloo College of Medicine, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 50 years old; 2. Patients with senile dementia, including Alzheimer's dementia, vascular dementia, frontotemporal dementia; 3. MMSE score <= 20 points; 4. Newly diagnosed patients with more than moderate dementia, or patients with more than moderate dementia who have been clearly diagnosed but have not been treated with memantine before; 5. A reliable caregiver.

Exclusion criteria

Exclusion criteria: 1. Allergic to the test drug or its related ingredients; 2. Patients with severe liver function impairment (ALT or AST level more than 3 times the upper limit of normal value); 3. Patients with severe renal function impairment (serum creatinine more than 3 times the upper limit of normal value); 4. Previous diagnosis of depression, bipolar disorder or other mental disorders; 5. Patients with poor compliance who cannot be treated according to the prescribed program; 6. Patients considered unsuitable for inclusion by other researchers.

Design outcomes

Primary

MeasureTime frame
mini-mental state examination, MMSE;

Secondary

MeasureTime frame
Alzheimer's Disease Collaborative Study-Activities of Daily Living Scale, ADCS-ADL;Neuropsychiatric Symptoms Questionnaire, NPI;Morisky Medication Adherence Questionnaire score, MMAS-8;

Countries

China

Contacts

Public ContactShunliang Xu

Department of Neurology, The Second Hospital, Cheeloo College of Medicine, Shandong University

slxu@sdu.edu.cn+86 176 6008 3339

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026