Alzheimer DiseasePhase 3NCT00506415

Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline

A Phase 3 study testing Rivastigmine 5 cm^2, Rivastigmine 10 cm^2 and Rivastigmine 15 cm^2 in people with Alzheimer Disease, run by Novartis Pharmaceuticals at 145 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 50 to 85 years
Conditions the study is for: Alzheimer Disease
What is being tested?: Rivastigmine 5 cm^2, Rivastigmine 10 cm^2 and Rivastigmine 15 cm^2
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,584 participants
Where: 145 sitesin 7 countries
Study dates: Jun 2007to May 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

145 sites in 7 countries.

Country

City, postcode or hospital

145 sites in 7 countries

United States65 sites

Novartis investigative site
Albany, New York, 12208
Novartis investigative site
Anaheim, California, 92804
Novartis investigative site
Atlanta, Georgia, 30341-4155
Novartis investigative site
Beaufort, South Carolina, 29902
Novartis investigative site
Beaver, Pennsylvania, 15009-1957
Novartis investigative site
Birmingham, Alabama, 35294
Novartis investigative site
Boca Raton, Florida, 33431
Novartis investigative site
Bradenton, Florida, 32405
Novartis investigative site
Brentwood, Tennessee, 37027-5240
Novartis investigative site
Canton, Ohio, 44718
Novartis investigative site
Carson, California, 90746
Novartis investigative site
Charleston, West Virginia, 25304
Novartis investigative site
Chicago, Illinois, 60611
Novartis investigative site
Columbia, Missouri, 65201
Novartis investigative site
Columbus, Ohio, 43220
Novartis investigative site
Corvallis, Oregon, 97330
Novartis investigative site
Costa Mesa, California, 92626
Novartis investigative site
Dallas, Texas, 75231
Novartis investigative site
Deerfield Beach, Florida, 33064
Novartis investigative site
Delray Beach, Florida, 33445
Novartis investigative site
Erie, Pennsylvania, 16506
Novartis investigative site
Flemington, New Jersey, 08822
Novartis investigative site
Flint, Michigan, 48532
Novartis investigative site
Flushing, Michigan, 48433
Novartis investigative site
Fort Collins, Colorado, 80524
Novartis investigative site
Fort Lauderdale, Florida, 33308
Novartis investigative site
Fort Worth, Texas, 76107
Novartis investigative site
Fullerton, California, 92835
Novartis investigative site
Gainesville, Florida, 32610
Novartis investigative site
Gilbert, Arizona, 85234
Novartis investigative site
Greensboro, North Carolina, 27401
Novartis investigative site
Greensburg, Pennsylvania, 15601
Novartis investigative site
Hattiesburg, Mississippi, 39401
Novartis Investigative Site
Honolulu, Hawaii, 96817
Novartis investigative site
Huntington, West Virginia, 25701
Novartis investigative site
Irving, Texas, 75062
Novartis investigative site
La Habra, California, 90631
Novartis investigative site
La Jolla, California, 92037
Novartis investigative site
Longmont, Colorado, 80501
Novartis investigative site
Macon, Georgia, 31201
Novartis investigative site
Miami Beach, Florida, 33140
Novartis investigative site
Morganton, North Carolina, 28655
Novartis investigative site
Nashville, Tennessee, 37203
Novartis investigative site
National City, California, 91950
Novartis investigative site
Nutley, New Jersey, 07110
Novartis investigative site
Ocean Springs, Mississippi, 39564
Novartis investigative site
Phoenix, Arizona, 85004
Novartis investigative site
Pittsburgh, Pennsylvania, 15243
Novartis investigative site
Pompano Beach, Florida, 33060
Novartis investigative site
Port Charlotte, Florida, 33952
Novartis investigative site
Portland, Oregon, 97225
Novartis investigative site
Redlands, California, 92374
Novartis investigative site
Roseville, Michigan, 48066
Novartis investigative site
San Francisco, California, 94115
Novartis investigative site
Somerset, New Jersey, 08873
Novartis investigative site
Springfield, Massachusetts, 01104
Novartis investigative site
St Louis, Missouri, 63141
Novartis investigative site
Summerville, South Carolina, 29485
Novartis investigative site
Sun City, Arizona, 85351
Novartis investigative site
Sunrise, Florida, 33351
Novartis investigative site
Syracuse, New York, 13210-1853
Novartis investigative site
Traverse City, Michigan, 49684-2340
Novartis investigative site
West Palm Beach, Florida, 33407
Novartis investigative site
Winston-Salem, North Carolina, 27103-4019
Novartis investigative site
Winston-Salem, North Carolina, 27103

Other trials in United States

Italy28 sites

Novartis investigative site
Ancona
Novartis investigative site
Arcugnano
Novartis investigative site
Arezzo
Novartis investigative site
Bari
Novartis investigative site
Bologna
Novartis investigative site
Brescia
Novartis investigative site
Cagliari
Novartis investigative site
Catania
Novartis investigative site
Città di Castello
Novartis investigative site
Cremona
Novartis investigative site
Ferrara
Novartis investigative site
Florence
Novartis investigative site
Foggia
Novartis investigative site
Genova
Novartis investigative site
La Spezia
Novartis investigative site
Milan, Milan
Novartis investigative site
Milan
Novartis investigative site
Milan
Novartis investigative site
Modena
Novartis investigative site
Naples
Novartis investigative site
Padova
Novartis investigative site
Pavia
Novartis investigative site
Perugia
Novartis investigative site
Pisa
Novartis investigative site
Rho
Novartis investigative site
Rome
Novartis investigative site
Torino
Novartis investigative site
Verona

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Germany19 sites

Novartis investigative site
Bad Neustadt/Saale
Novartis investigative site
Berlin
Novartis investigative site
Bonn
Novartis investigative site
Burg
Novartis investigative site
Cologne
Novartis investigative site
Düsseldorf
Novartis investigative site
Frankfurt
Novartis investigative site
Giessen
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Krefeld
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Leipzig
Novartis investigative site
Magdeburg
Novartis investigative site
Mannheim
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Marburg
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München
Novartis investigative site
Münster
Novartis investigative site
Nuremberg
Novartis investigative site
Stralsund
Novartis investigative site
Stuttgart
Novartis investigative site
Würzburg

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Canada14 sites

Novartis investigative site
Calgary
Novartis investigative site
Edmonton
Novartis investigative site
Greenfield Park
Novartis investigative site
Halifax
Novartis investigative site
London
Novartis investigative site
Montreal
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Ottawa
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Peterborough
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Québec
Novartis investigative site
Regina
Novartis investigative site
Toronto, Ontario
Novartis investigative site
Toronto
Novartis investigative site
Vancouver
Novartis investigative site
Winnipeg

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France14 sites

Novartis investigative site
Bordeaux
Novartis investigative site
Bourg-en-Bresse
Novartis investigative site
Caen
Novartis investigative site
Cherbourg
Novartis investigative site
Dijon, Burgundy
Novartis investigative site
Dijon
Novartis investigative site
Fains-Véel, Alsace Lorraine
Novartis investigative site
Limoges
Novartis investigative site
Montpellier
Novartis investigative site
Nice
Novartis investigative site
Paris
Novartis investigative site
Reims, Champagne-Ardenne
Novartis investigative site
Rennes
Novartis investigative site
Rodez

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Switzerland3 sites

Novartis investigative site
Basel
Novartis investigative site
Biel
Novartis investigative site
Mendrisio

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Spain2 sites

Novartis investigative site
Barcelona
Novartis investigative site
Palma de Mallorca

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About this study

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

Conditions: Alzheimer Disease
Being tested: Rivastigmine 5 cm^2, Rivastigmine 10 cm^2, Rivastigmine 15 cm^2, Placebo to 15 cm^2 patch, Placebo to 10 cm^2 patch
Keywords: Alzheimer's, Patch, Cognitive, Decline
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rivastigmine 5 cm^2Drug
Also called Exelon®
5 cm^2 transdermal patch
Rivastigmine 10 cm^2Drug
Also called Exelon®
10 cm^2 transdermal patch.
Rivastigmine 15 cm^2Drug
Also called Exelon®
15 cm^2 transdermal patch.
Placebo to 15 cm^2 patchDrug
Placebo of rivastigmine transdermal patch 15 cm^2.
Placebo to 10 cm^2 patchDrug
Placebo of rivastigmine transdermal patch 10 cm^2.

Study groups in NCT00506415
Study group	Role	What they receive
Open label: Rivastigmine (5 cm^2 / 10 cm^2)	Experimental	Rivastigmine 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. Receives: Drug: Rivastigmine 5 cm^2; Drug: Rivastigmine 10 cm^2
Double blind: Rivastigmine (10 cm^2)	Experimental	Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period. Receives: Drug: Rivastigmine 10 cm^2; Drug: Placebo to 15 cm^2 patch
Double blind: Rivastigmine (15 cm^2)	Experimental	Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period. Receives: Drug: Rivastigmine 15 cm^2; Drug: Placebo to 10 cm^2 patch
Extended open label Rivastigmine (10 cm^2)	Experimental	Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period. Receives: Drug: Rivastigmine 10 cm^2

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at 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.
Measured: Baseline and week 48 of double blind period
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
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.
Measured: Baseline and week 48 of double blind period

Secondary outcomes (5)

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
Functional decline was defined by either an at least 1 point decrease in the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) subscale score in a visit and confirmed by the following visit/assessment or at least 2 points decrease from the double blind randomization baseline.
Measured: 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
Change from baseline to week 48 in total time to perform Trail Making Test (TMT) part A. This test provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. The score represents the amount of time required to complete the task. Total values for TMT part A range between 0 and 300 seconds. A negative change indicates an improvement from baseline.
Measured: 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
Change from baseline to week 48 in total time to perform Trail Making Test (TMT) part B. This test provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. TMT has two parts: Part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-Part B except the person must alternate between numbers and letters. Total values for TMT part B range between 0 and 420 seconds. A negative change from baseline indicates an improvement in condition.
Measured: Baseline and week 48 of double blind period
Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period
Change from baseline to week 48 as assessed by the Neuropsychiatric Inventory (NPI)-10 total score. The scale consists of 10 domains that are rated for both frequency (range 1-4) and severity (range 1-3). A composite score for each domain is calculated (frequency x severity) which ranges from 1 to 12. There is a leading question for each item. If the symptom is not present then the frequency, severity and distress scores are not completed. In this case the score is 0 for the item. The sum of the composite scores yields the NPI-10 total score (range 0-120). A negative change in score indicates an improvement from baseline (symptom reduction).
Measured: Baseline and week 48 of double blind period
Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Measured: 30 days after a maximum of 96 weeks treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007May 2011

First posted25 Jul 2007 (estimated)
Study startJun 2007
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,584 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00506415
Sponsor's protocol ID: CENA713D2340
Status last verified: Sep 2012
First submitted: 20 Jul 2007
Last updated: 19 Sep 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 25755685
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.
PubMed 23982674

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00506415
Acronym / sponsor ID: CENA713D2340
Conditions: Alzheimer Disease
Keywords: Alzheimer's, Patch, Cognitive, Decline
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,584 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 25 Jul 2007 (estimated)
Results: Posted 19 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Open label: Rivastigmine (5 cm^2 / 10 cm^2)	Experimental	Drug: Rivastigmine 5 cm^2, Drug: Rivastigmine 10 cm^2Rivastigmine 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)	Experimental	Drug: Rivastigmine 10 cm^2, Drug: Placebo to 15 cm^2 patchRivastigmine 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)	Experimental	Drug: Rivastigmine 15 cm^2, Drug: Placebo to 10 cm^2 patchRivastigmine 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)	Experimental	Drug: Rivastigmine 10 cm^2Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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),

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rivastigmine 5 cm^2Also: Exelon®5 cm^2 transdermal patch	Drug	Open label: Rivastigmine (5 cm^2 / 10 cm^2)
Rivastigmine 10 cm^2Also: Exelon®10 cm^2 transdermal patch.	Drug	Double blind: Rivastigmine (10 cm^2), Extended open label Rivastigmine (10 cm^2), Open label: Rivastigmine (5 cm^2 / 10 cm^2)
Rivastigmine 15 cm^2Also: Exelon®15 cm^2 transdermal patch.	Drug	Double blind: Rivastigmine (15 cm^2)
Placebo to 15 cm^2 patchPlacebo of rivastigmine transdermal patch 15 cm^2.	Drug	Double blind: Rivastigmine (10 cm^2)
Placebo to 10 cm^2 patchPlacebo of rivastigmine transdermal patch 10 cm^2.	Drug	Double blind: Rivastigmine (15 cm^2)

Primary outcome

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period
Time frame: 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
Time frame: 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.

5 secondary outcomes

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
Time frame: 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
Time frame: 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
Time frame: Baseline and week 48 of double blind period
Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period
Time frame: Baseline and week 48 of double blind period
Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Time frame: 30 days after a maximum of 96 weeks treatment

Results and safety

Results posted to the registry on 19 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)	1,584	1,085
Double Blind: Rivastigmine (10 cm^2)	0	0
Double Blind: Rivastigmine (15 cm^2)	0	0
Extended Open Label (10 cm^2)	0	0

Primary outcome: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period

Time frame: Baseline and week 48 of double blind period. Mean (Standard Deviation). Unit: units on a scale

Measure	Double Blind: Rivastigmine (10 cm^2) n = 268	Double Blind: Rivastigmine (15 cm^2) n = 264
Value	4.9 (7.49)	4.1 (8.00)

Population analysed: Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.

Primary outcome: 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

Time frame: Baseline and week 48 of double blind period. Mean (Standard Deviation). Unit: units on a scale

Measure	Double Blind: Rivastigmine (10 cm^2) n = 271	Double Blind: Rivastigmine (15 cm^2) n = 265
Value	-6.2 (8.78)	-4.4 (8.21)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days after a maximum of 96 weeks treatment. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)	227 of 1,582 (14.3%)	732 of 1,582 (46.3%)	Not reported
Double Blind: Rivastigmine (10 cm^2)	44 of 283 (15.5%)	110 of 283 (38.9%)	Not reported
Double Blind: Rivastigmine (15 cm^2)	44 of 280 (15.7%)	151 of 280 (53.9%)	Not reported
Extended Open Label: Rivastigmine (10 cm^2)	59 of 457 (12.9%)	112 of 457 (24.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25755685Molinuevo 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.
Derived from this study: PubMed 23982674Grossberg 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.

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A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

145 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivastigmine 5 cm^2, Rivastigmine 10 cm^2 and Rivastigmine 15 cm^2 in people with Alzheimer Disease, run by Novartis Pharmaceuticals at 145 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States, Italy, Germany, Canada, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period (time frame: Baseline and week 48 of double blind period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00506415, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2012.