A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.

A Prospective, 16 Week, Phase IV Study to Evaluate Safety, Tolerability and Effectiveness in Patients With Severe Dementia of the Alzheimer's Type Exposed to Rivastigmine (Exelon)15cm2 Transdermal Patch

ClinicalTrials.gov Identifier: NCT02989402

Novartis Reference Number: CENA713DIN01

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a multicenter, prospective, phase IV study evaluating safety, tolerability and effectiveness of rivastigmine 27 mg -15 cm2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician.

Condition 
Alzheimer's Disease
Phase 
Phase 4
Overall status 
Recruiting
Enrollment count 
102 participants
Start date 
Dec 31, 2018
Completion date 
Dec 31, 2021
Gender 
All
Age(s)
(Child, Adult, Older Adult)

Interventions

Drug
Rivastigmine
15 cm2 patch sizes loaded with 27 mg of rivastigmine

Eligibility Criteria

Inclusion Criteria:

Patients willing to participate in the study by providing written informed consent.
Patients diagnosed with severe dementia secondary to Alzheimer's disease (AD) 3 .Patient's prescribed with rivastigmine 27mg -15 cm2 transdermal patch as per discretion of treating physician

Exclusion Criteria:

Contraindication as per PI
Patients simultaneously participating in other studies
Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) /until the expected PD effect has returned to baseline (for biologics)], whichever is longer.
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes

Study Locations

India
Novartis Investigative Site
Recruiting
Bangalore, 560 055
Karnataka
India
Novartis Investigative Site
Recruiting
Bangalore, 560052
Karnataka
India
Novartis Investigative Site
Recruiting
Banglaore, 560052
Karnataka
India
Novartis Investigative Site
Recruiting
Bengaluru, 560005
Karnataka
India
Novartis Investigative Site
Recruiting
Mumbai, 400 053
Maharashtra
India
Novartis Investigative Site
Recruiting
Hyderabad, 500082
Telangana
India
Novartis Investigative Site
Recruiting
Lucknow, 226003
Uttar Pradesh
India
Novartis Investigative Site
Recruiting
Kolkata, 700 107
West Bengal
India

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]