A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rivastigmine patch 15 cm2 patch sizes loaded with 27 mg of rivastigmine |
Drug: Rivastigmine
15 cm2 patch sizes loaded with 27 mg of rivastigmine
|
Outcome Measures
Primary Outcome Measures
- Number of participants with Adverse events as a measure of Safety and tolerability [16 weeks]
Secondary Outcome Measures
- Change from baseline in Mini-Mental State Examination (MMSE [baseline, 16 weeks]
The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 30, with higher scores indicating better function. MMSE shall be recorded at the start and end of study provided it is a part of routine clinical practic
- Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) score [baseline, 16 weeks]
This is a tool to assess the ability of patients with moderate to severe dementia to perform activities of daily living. The ADCS-ADL SIV assessment is done at start and end of visit. The assessment includes 19 questions. The score for each questions ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13, questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. The total score ranges from 0 - 54. Higher scores indicate less functional impairment and greater competence.
- Mean Caregiver Medication Questionnaire (CMQ) score [baseline, 16 weeks]
The total compliance is rated on an 10 point scale: 0 = "never took the medication as prescribed"; maximum of 10 = "always took the medication as prescribed."
- Number of participants with a skin irritation [baseline, 16 weeks]
The following score system will be used to assess skin irritation: I. Dermal response: 0 = No erythema (normal skin) = Erythema barely visible = Mild erythema = Moderate erythema = Severe erythema = Severe erythema with vesicles or blisters II. Other effects: O : Edema P : Papules (many small, red, solid, elevated lesions, surface of reaction with granular feeling) V : Small vesicles (< 0.5 cm) circumscribed elevations with visible fluid B : Large blister (> 0.5 cm) circumscribed elevations with visible fluidPu : Pustules (inflammatory small elevations containing purulent exudate) H : Hyperpigmentation (increase of the usual pigmentation limited to the patch test area) W : Weeping or oozing (may be a sign of vesiculation or blistering manifested by crusting) S : Extension of the reaction beyond patch-test site (on skin area where no test product was applied) A : Marked reaction to adhesive patch
- Number of participants with a urinary tract infection (UTI) [16 weeks]
Urine samples will be collected to assess the number of patients with UTI.
- Change from baseline in patch adhesion score [baseline, 16 weeks]
Patch adhesion to the skin will be evaluated by the caregiver. An estimate of the patch adherence will be provided and graded according to the patch adhesiveness score for the intervals between the scheduled outpatient visits. Following scores should be used to capture comments relating to patch adhesion: 0 = 90 % adhered (essentially no lift off of the skin) = 75% to < 90% adhered (some edges only lifting off of the skin) = 50% to < 75% adhered (less than half of the patch lifting off the skin) = < 50% adhered but not detached (more than half the system lifting off of the skin without falling off) = the patch was completely detached. The total score ranges from 1 to 4 where a higher score indicates less adhesion.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Bangalore | Karnataka | India | 560 055 |
| 2 | Novartis Investigative Site | Bangalore | Karnataka | India | 560052 |
| 3 | Novartis Investigative Site | Banglaore | Karnataka | India | 560052 |
| 4 | Novartis Investigative Site | Bengaluru | Karnataka | India | 560005 |
| 5 | Novartis Investigative Site | Mumbai | Maharashtra | India | 400 053 |
| 6 | Novartis Investigative Site | Hyderabad | Telangana | India | 500082 |
| 7 | Novartis Investigative Site | Lucknow | Uttar Pradesh | India | 226003 |
| 8 | Novartis Investigative Site | Kolkata | West Bengal | India | 700 107 |
| 9 | Novartis Investigative Site | Kolkata | West Bengal | India | 700017 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CENA713DIN01