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

Last Update: Mar 14, 2022

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

Start date

Dec 31, 2018

Completion date

Jan 02, 2023

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