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Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Primary Purpose

Alzheimer's Disease, Dementia, Alzheimer Type

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rivastigmine transdermal patch
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Dementia

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of dementia of the Alzheimer's type Males, and females who are surgically sterile or one year postmenopausal A primary caregiver willing to accept responsibility for supervising the treatment Exclusion Criteria: Any condition (other than Alzheimer's) that could explain patient's dementia An advanced, severe or unstable disease that may put the patient at special risk Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease

Sites / Locations

Outcomes

Primary Outcome Measures

Change in cognition from baseline at week 24
Global clinical impression of change from baseline at week 24

Secondary Outcome Measures

Change from baseline at week 24 in activities of daily living
Change from baseline at week 24 in behavioral symptoms
Change from baseline at week 24 in global cognitive testing
Change from baseline at week 24 in executive function
Change from baseline at week 24 in attention

Full Information

First Posted
December 10, 2004
Last Updated
October 12, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00099242
Brief Title
Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Official Title
Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia, Alzheimer Type
Keywords
Alzheimer's Disease, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1040 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rivastigmine transdermal patch
Primary Outcome Measure Information:
Title
Change in cognition from baseline at week 24
Title
Global clinical impression of change from baseline at week 24
Secondary Outcome Measure Information:
Title
Change from baseline at week 24 in activities of daily living
Title
Change from baseline at week 24 in behavioral symptoms
Title
Change from baseline at week 24 in global cognitive testing
Title
Change from baseline at week 24 in executive function
Title
Change from baseline at week 24 in attention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of dementia of the Alzheimer's type Males, and females who are surgically sterile or one year postmenopausal A primary caregiver willing to accept responsibility for supervising the treatment Exclusion Criteria: Any condition (other than Alzheimer's) that could explain patient's dementia An advanced, severe or unstable disease that may put the patient at special risk Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease
Facility Information:
City
Orange
State/Province
California
ZIP/Postal Code
92868-3298
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33154
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
City
Manchester Township
State/Province
New Jersey
ZIP/Postal Code
08759
Country
United States
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Santiago
Country
Chile
City
Valparaiso
Country
Chile
City
Brno-Bohunice
Country
Czechia
City
Brno
Country
Czechia
City
Hradec Kralove
Country
Czechia
City
Olomouc
Country
Czechia
City
Prague
Country
Czechia
City
Glostrup
Country
Denmark
City
Hillerod
Country
Denmark
City
Kobenhavn
Country
Denmark
City
Kuopio
Country
Finland
City
Investigative sites
Country
Germany
City
Guatemala City
Country
Guatemala
City
Beersheva
Country
Israel
City
Hifa
Country
Israel
City
Jerusalem
Country
Israel
City
Petach Tikva
Country
Israel
City
Tel Aviv
Country
Israel
City
Lido di Camaiore
Country
Italy
City
Milano
Country
Italy
City
Pescara
Country
Italy
City
Chungbuk
Country
Korea, Republic of
City
KyungKi-province
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Guadalajara Jalisco
Country
Mexico
City
Mexico D.F.
Country
Mexico
City
Monterrey Nuevo Leon
Country
Mexico
City
Bodo
Country
Norway
City
Oslo
Country
Norway
City
Tromso
Country
Norway
City
Trondheim
Country
Norway
City
Lima
Country
Peru
City
Gdansk
Country
Poland
City
Lublin
Country
Poland
City
Poznan
Country
Poland
City
Szczecin
Country
Poland
City
Warszawa
Country
Poland
City
Amadora
Country
Portugal
City
Coimbra
Country
Portugal
City
Bayamon
ZIP/Postal Code
00959
Country
Puerto Rico
City
Moscow
Country
Russian Federation
City
Saint-Petersburg
Country
Russian Federation
City
Bratislava
Country
Slovakia
City
Michalovce
Country
Slovakia
City
Goteborg
Country
Sweden
City
Kalmar
Country
Sweden
City
Stockholm
Country
Sweden
City
Uppsala
Country
Sweden
City
Kaohsiung
Country
Taiwan
City
Taichung
Country
Taiwan
City
Taipei
Country
Taiwan
City
Tao-Yuan
Country
Taiwan
City
Ciudad Merida
State/Province
Estado Merida
Country
Venezuela

12. IPD Sharing Statement

Citations:
PubMed Identifier
27681702
Citation
Lefevre G, Callegari F, Gsteiger S, Xiong Y. Effects of Renal Impairment on Steady-State Plasma Concentrations of Rivastigmine: A Population Pharmacokinetic Analysis of Capsule and Patch Formulations in Patients with Alzheimer's Disease. Drugs Aging. 2016 Oct;33(10):725-736. doi: 10.1007/s40266-016-0405-y.
Results Reference
derived
PubMed Identifier
21312297
Citation
Alva G, Grossberg GT, Schmitt FA, Meng X, Olin JT. Efficacy of rivastigmine transdermal patch on activities of daily living: item responder analyses. Int J Geriatr Psychiatry. 2011 Apr;26(4):356-63. doi: 10.1002/gps.2534.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

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