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Rivastigmine 5 cm^2

Phase 3

Alzheimer Disease | Small molecule | Neurology |Novartis AG|Last Updated: Sep 19, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment1,584

FDA Designations

No designations recorded

Clinical trial landscape

Rivastigmine 5 cm^2 · 1 trial · 1 indication

Phase 3 1
NCT00506415Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive DeclineAlzheimer Disease
COMPLETED1,584 Analytics
PHASE3COMPLETED
Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period
Baseline and week 48 of double blind period

The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) subscale comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline.

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
Baseline and week 48 of double blind period

The Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) is a 16 item subscale of the caregiver-based ADCS-IADL scale, developed for the use in dementia studies. The ADCS-IADL total score ranges from 0 to 56, with higher scores indicating less severe impairment. A positive change indicates an improvement from baseline.

Secondary Endpoints

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
390 days was the maximum
Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period
Baseline and week 48 of double blind period
Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period
Baseline and week 48 of double blind period
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Open label: Rivastigmine (5 cm^2 / 10 cm^2)EXPERIMENTALRivastigmine 5 cm\^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm\^2 transdermal patch once a day from week 4 to week 24, 36 or 48.
Double blind: Rivastigmine (10 cm^2)EXPERIMENTALRivastigmine transdermal patch 10 cm\^2 and placebo to rivastigmine 15 cm\^2 once daily for 48 weeks during the double blind period.
Double blind: Rivastigmine (15 cm^2)EXPERIMENTALRivastigmine transdermal patch 15 cm\^2 and placebo to rivastigmine 10 cm\^2 once daily for 48 weeks during double blind period.
Extended open label Rivastigmine (10 cm^2)EXPERIMENTALRivastigmine 10 cm\^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.

Interventions

NameTypeDescription
Rivastigmine 5 cm^2DRUG5 cm\^2 transdermal patch
Rivastigmine 10 cm^2DRUG10 cm\^2 transdermal patch.
Rivastigmine 15 cm^2DRUG15 cm\^2 transdermal patch.
Placebo to 15 cm^2 patchDRUGPlacebo of rivastigmine transdermal patch 15 cm\^2.
Placebo to 10 cm^2 patchDRUGPlacebo of rivastigmine transdermal patch 10 cm\^2.
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Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites145

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 patien...

Countries:United StatesCanadaFranceGermanyItalySpainSwitzerland
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Frequently asked questions about Rivastigmine 5 cm^2

What is Rivastigmine 5 cm^2 used for?

Rivastigmine 5 cm^2 is a small molecule being developed for Alzheimer's Disease. It is an investigational treatment studied in patients with probable Alzheimer's Disease, including those showing cognitive decline. The drug is administered as a patch and is intended to address symptoms of this neurological condition.

Who makes Rivastigmine 5 cm^2?

Rivastigmine 5 cm^2 is developed by Novartis AG, a company traded under the ticker NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of this patch formulation in patients with Alzheimer's Disease.

What phase is Rivastigmine 5 cm^2 in?

Rivastigmine 5 cm^2 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trials are completed, and the drug remains under evaluation for Alzheimer's Disease.

What clinical trials is Rivastigmine 5 cm^2 in?

Rivastigmine 5 cm^2 has been studied in two completed Phase 3 trials. NCT00428389 evaluated switching from donepezil to rivastigmine patch in 262 patients. NCT00506415 compared rivastigmine 10 and 15 cm^2 patches in 1584 patients with cognitive decline. Both trials involved Alzheimer's Disease patients aged 50 and older.

Is Rivastigmine 5 cm^2 the same as rivastigmine patch?

Rivastigmine 5 cm^2 refers to a specific patch size of rivastigmine. The clinical trials studied rivastigmine patches of various sizes, including 10 and 15 cm^2. The 5 cm^2 patch is one formulation within this development program for Alzheimer's Disease.