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Rivastigmine transdermal patch in Alzheimer's DIsease: a real-world evaluation of Caregiver burden

Rivastigmine transdermal patch in Alzheimer's DIsease: a real-world evaluation of Caregiver burden

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026313
Enrollment
Unknown
Registered
2019-09-29
Start date
2019-09-27
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

Alzheimer's disease

Interventions

Patch:Rivastigmine transdermal patch
Oral:Oral anti-dementia drugs

Sponsors

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 50 years, male or female; 2. Meet the NINCDS-ADRDA criteria for probable AD 3. MMSE score is 10-26 points (including 10 and 26 points); 4. Hachiski ischemia index score(HIS) <= 4; 5. Hamilton depression scale (HAMD) score <= 7; 6. Plain scan of brain MRI(include at least the T1, T2, FLAIR sequence) and/or Longitudinal oblique coronal position of vertical hippocampu is essential: for objects <= 70 years old Fazeca scale for WM lesions should be less than grade 1; for subjects over 70 years old Fazeca scale for WM lesions should be less than grade 2; There were less than or equal to 2 lacunar cerebral infarction larger than 2cm in diameter, and thereare no infarction in key parts such as thalamus, hippocampus, entorhinal cortex, paracorhinal cortex, cortex and other subcortical gray matter nuclei. MRI shows that AD is the most likely. 7. Good audiovisual, free movement, and able to cooperate with examination and treatment; 8. Have at least one reliable caregiver who has at least 2 hours of daily contact with the patient; 9. Informed consent should be signed.

Exclusion criteria

Exclusion criteria: 1. Dementia caused by other reasons: vascular dementia, and central nervous system infection, Creutzfeldt-Jakob disease, Parkinson's disease, Huntington's disease, DLB, other physical and chemical factors (such as, alcoholism, drug poisoning of carbon monoxide poisoning, etc.), body disease (such as hepatic encephalopathy, pulmonary encephalopathy), Diseases of the endocrine system (such as thyroid disease, parathyroid disease) and dementia caused by vitamins or other causes; 2. Participated in all kinds of types of clinical trials/studies within 3 months before the study begin; 3. Patients with contraindications to research drugs; 4. Patients with contraindications to MRI; 5. Currently, anticholinergic drugs (such as atropine, anisodamine, scopolamine, scopolamine butylbromide, belladonna, prubenectin, etc.) and/or cholinergic agents (such as acetylcholine, tranexamethyl choline, formylcholine, furrotin, etc.) are used; 6. Patients considered unsuitable for inclusion by the researchers, in addition to other reasons mentioned above.

Design outcomes

Primary

MeasureTime frame
ZBI score;

Secondary

MeasureTime frame
MMSE score;ADL score;NPI score;CIBIC-plus score;Morisky score;

Countries

China

Contacts

Public ContactLiu Jun

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

docliujun@126.com+86 13609794537

Outcome results

None listed

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