Study to assess safety, tolerability and effectiveness in patients with severe dementia exposed to exelon

A prospective, 16 week, phase IV study to evaluate safety, tolerability and effectiveness in patients with severe dementia of the AlzheimerÃ¢â?¬â?¢s type exposed to rivastigmine (Exelon)15cm2 transdermal patch

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/02/011948

Enrollment

102

Registered

2018-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: null- Severe dementia of the AlzheimerÃ¢â?¬â?¢s type

Interventions

Intervention1: Rivastigmine 27 mg -15 cm2 transdermal patch: This is a multicenter, prospective, phase IV study evaluating safety, tolerability and effectiveness of rivastigmine 27 mg -15 cm2 transder

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients willing to participate in the study by providing written informed consent. 2)Patients diagnosed with severe dementia secondary to AlzheimerÃ¢â?¬•s disease (AD) 3)PatientÃ¢â?¬•s prescribed with rivastigmine 27mg -15 cm2 transdermal patch as per discretion of treating physician

Exclusion criteria

Exclusion criteria: 1)Contraindication as per PI 2)Patients simultaneously participating in other studies

Design outcomes

Primary

Measure	Time frame
To obtain safety data in patients with severe dementia of the AlzheimerÃ¢â?¬â?¢s type treated with rivastigmine 27 mg -15 cm2 transdermal patchTimepoint: Overall study period (from FPFV to LPLV)	—

Secondary

Measure	Time frame
1)To assess patients compliance to study medication 2)To assess the skin tolerability 3)To assess the proportion of patients with UTI 4)To evaluate treatment effect by rivastigmine 27 mg -15 cm2 transdermal patch by assessing the changes in MMSE 5)To evaluate treatment efficacy by rivastigmine 27 mg -15 cm2 transdermal patch by assessing the changes in ADCS-Activities of Daily Living Inventory Ã¢â?¬â?? Severe Impairment Version (ADCS-ADL SIV) Score Timepoint: During 16 weeks treatment period	—

Measure

Time frame

1)To assess patients compliance to study medication 2)To assess the skin tolerability 3)To assess the proportion of patients with UTI 4)To evaluate treatment effect by rivastigmine 27 mg -15 cm2 transdermal patch by assessing the changes in MMSE 5)To evaluate treatment efficacy by rivastigmine 27 mg -15 cm2 transdermal patch by assessing the changes in ADCS-Activities of Daily Living Inventory Ã¢â?¬â?? Severe Impairment Version (ADCS-ADL SIV) Score Timepoint: During 16 weeks treatment period

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Countries

India

Contacts

Public ContactDr Sneha Thakur

Novartis India Limited

sneha.thakur@novartis.com912250243632

Outcome results

None listed

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