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

Phase 4

Recruiting

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

• Registration Number: CTRI/2018/02/011948
• Lead Sponsor: ovartis India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)Patients willing to participate in the study by providing written informed consent.

2)Patients diagnosed with severe dementia secondary to Alzheimerââ?¬•s disease (AD)

3)Patientââ?¬•s prescribed with rivastigmine 27mg -15 cm2 transdermal patch as per discretion of treating physician

Exclusion Criteria

1)Contraindication as per PI

2)Patients simultaneously participating in other studies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To obtain safety data in patients with severe dementia of the Alzheimer�s type treated with rivastigmine 27 mg -15 cm2 transdermal patchTimepoint: Overall study period (from FPFV to LPLV)

Secondary Outcome Measures

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