Clinical trial NCT00506415: Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline
Official title: A 48-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Evaluation of the Comparative Efficacy, Safety, and Tolerability of Exelon® 10 and 15 cm^2 Patch in Patients With Mild to Moderate Alzheimer's Disease (AD) Showing Functional and Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer Disease
Keywords: Alzheimer's
Patch
Cognitive
Decline
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 1584
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm\^2.


Eligibility criteria: Inclusion Criteria:

* Male or female patients between 50 and 85 years of age with a diagnosis of probable Alzheimers Disease,
* Baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive,
* A primary caregiver willing to accept responsibility for supervising treatment, assessing the patient's condition throughout the study, and for providing input into efficacy assessments.
* For double blind only: Meet the decline criteria of functional (as assessed by the investigator) and cognitive (assessed by a 1 point reduction in Mini-Mental State Examination) score between visits or a 3 point reduction from baseline) decline at weeks 23, 36 or 48.

Exclusion Criteria:

* Presence of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments or put the patient at particular risk,
* Any medical or neurological condition other than Alzheimers Disease that could explain the patient's dementia,
* A diagnosis of probable or possible vascular dementia,
* A current diagnosis of unsuccessfully-treated depression, or any other mental disorder that may interfere with the evaluation of the patient's response to study medication,
* A history or current diagnosis of cerebrovascular disease (e.g. stroke),
* A current diagnosis of severe or unstable cardiovascular disease (e.g. unstable coronary artery disease).

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period
timeFrame: Baseline and week 48 of double blind period
measure: Change in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale Score From Baseline to Week 48 of Double Blind Period
timeFrame: Baseline and week 48 of double blind period
Secondary outcomes:
measure: Time to Functional Decline as Measured by Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale During the Double Blind Period
timeFrame: 390 days was the maximum
measure: Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period
timeFrame: Baseline and week 48 of double blind period
measure: Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period
timeFrame: Baseline and week 48 of double blind period
measure: Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period
timeFrame: Baseline and week 48 of double blind period
measure: Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
timeFrame: 30 days after a maximum of 96 weeks treatment
Other outcomes:
Locations:
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state: California
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city: Milano
country: Italy
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state: Milan
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country: Italy
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city: Firenze
country: Italy
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city: La Spezia
country: Italy
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country: Italy
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country: Italy
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country: Italy
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city: Napoli
country: Italy
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city: Padova
country: Italy
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city: Pavia
country: Italy
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city: Perugia
country: Italy
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city: Pisa
country: Italy
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city: Rho
country: Italy
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city: Rome
country: Italy
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city: Torino
country: Italy
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city: Verona
country: Italy
facility: Novartis investigative site
city: Barcelona
country: Spain
facility: Novartis investigative site
city: Palma de Mallorca
country: Spain
facility: Novartis investigative site
city: Basel
country: Switzerland
facility: Novartis investigative site
city: Biel
country: Switzerland
facility: Novartis investigative site
city: Mendrisio
country: Switzerland
facility: Novartis investigative site
Study officials:
References:
citation: Molinuevo JL, Frolich L, Grossberg GT, Galvin JE, Cummings JL, Krahnke T, Strohmaier C. Responder analysis of a randomized comparison of the 13.3 mg/24 h and 9.5 mg/24 h rivastigmine patch. Alzheimers Res Ther. 2015 Mar 8;7(1):9. doi: 10.1186/s13195-014-0088-8. eCollection 2015.
citation: Grossberg G, Cummings J, Frolich L, Bellelli G, Molinuevo JL, Krahnke T, Strohmaier C. Efficacy of higher dose 13.3 mg/24 h rivastigmine patch on instrumental activities of daily living in patients with mild-to-moderate Alzheimer's disease. Am J Alzheimers Dis Other Demen. 2013 Sep;28(6):583-91. doi: 10.1177/1533317513495104.