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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Rivastigmine 5 cm^2

Rivastigmine 10 cm^2

Rivastigmine 15 cm^2

Placebo to 15 cm^2 patch

Placebo to 10 cm^2 patch

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's, Patch, Cognitive, Decline

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Open label: Rivastigmine (5 cm^2 / 10 cm^2)

Double blind: Rivastigmine (10 cm^2)

Double blind: Rivastigmine (15 cm^2)

Extended open label Rivastigmine (10 cm^2)

Arm Description

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.

Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.

Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.

Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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).

Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events

Full Information

NCT ID

NCT00506415

First Posted

July 20, 2007

Last Updated

September 17, 2012

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00506415

Brief Title

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

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

Alzheimer's, Patch, Cognitive, Decline

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1584 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open label: Rivastigmine (5 cm^2 / 10 cm^2)

Arm Type

Experimental

Arm Description

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.

Arm Title

Double blind: Rivastigmine (10 cm^2)

Arm Type

Experimental

Arm Description

Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.

Arm Title

Double blind: Rivastigmine (15 cm^2)

Arm Type

Experimental

Arm Description

Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.

Arm Title

Extended open label Rivastigmine (10 cm^2)

Arm Type

Experimental

Arm Description

Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.

Intervention Type

Drug

Intervention Name(s)

Rivastigmine 5 cm^2

Other Intervention Name(s)

Exelon®

Intervention Description

5 cm^2 transdermal patch

Intervention Type

Drug

Intervention Name(s)

Rivastigmine 10 cm^2

Other Intervention Name(s)

Exelon®

Intervention Description

10 cm^2 transdermal patch.

Intervention Type

Drug

Intervention Name(s)

Rivastigmine 15 cm^2

Other Intervention Name(s)

Exelon®

Intervention Description

15 cm^2 transdermal patch.

Intervention Type

Drug

Intervention Name(s)

Placebo to 15 cm^2 patch

Intervention Description

Placebo of rivastigmine transdermal patch 15 cm^2.

Intervention Type

Drug

Intervention Name(s)

Placebo to 10 cm^2 patch

Intervention Description

Placebo of rivastigmine transdermal patch 10 cm^2.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline and week 48 of double blind period

Title

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

Description

Time Frame

Baseline and week 48 of double blind period

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

390 days was the maximum

Title

Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period

Description

Time Frame

Baseline and week 48 of double blind period

Title

Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period

Description

Time Frame

Baseline and week 48 of double blind period

Title

Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period

Description

Time Frame

Baseline and week 48 of double blind period

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

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Birmingham

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Italy

Facility Name

Novartis investigative site

City

Milan

Country

Italy

Facility Name

Novartis investigative site

City

Modena

Country

Italy

Facility Name

Novartis investigative site

City

Napoli

Country

Italy

Facility Name

Novartis investigative site

City

Padova

Country

Italy

Facility Name

Novartis investigative site

City

Pavia

Country

Italy

Facility Name

Novartis investigative site

City

Perugia

Country

Italy

Facility Name

Novartis investigative site

City

Pisa

Country

Italy

Facility Name

Novartis investigative site

City

Rho

Country

Italy

Facility Name

Novartis investigative site

City

Rome

Country

Italy

Facility Name

Novartis investigative site

City

Torino

Country

Italy

Facility Name

Novartis investigative site

City

Verona

Country

Italy

Facility Name

Novartis investigative site

City

Barcelona

Country

Spain

Facility Name

Novartis investigative site

City

Palma de Mallorca

Country

Spain

Facility Name

Novartis investigative site

City

Basel

Country

Switzerland

Facility Name

Novartis investigative site

City

Biel

Country

Switzerland

Facility Name

Novartis investigative site

City

Mendrisio

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

25755685

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.

Results Reference

derived

PubMed Identifier

23982674

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.

Results Reference

derived

Learn more about this trial

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

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

Alzheimer Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial