Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44

PHASE4CompletedINTERVENTIONAL
Enrollment

716

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

January 31, 2012

Study Completion Date

June 30, 2012

Conditions
Alzheimer's Disease
Interventions
DRUG

Rivastigmine 4.6 mg/24 h (5 cm^2)

Rivastigmine was supplied in a 5 cm\^2 patch which released 4.6 mg/24 h. Patches were changed daily.

DRUG

Rivastigmine 9.5 mg/24 h (10 cm^2)

Rivastigmine was supplied in a 10 cm\^2 patch which released 9.5 mg/24 h. Patches were changed daily.

DRUG

Rivastigmine 13.3 mg/24 h (15 cm^2)

Rivastigmine was supplied in a 15 cm\^2 patch which released 13.3 mg/24 h. Patches were changed daily.

DRUG

Placebo

Placebo patches were identical in size and composition to the corresponding rivastigmine patches, except that they did not contain rivastigmine. Patches were changed daily.

Trial Locations (95)

10021

Eastside Comprehensive medical Center, LLC, New York

10305

Behavioral Medical Research of Staten Island, Staten Island

10312

Richmond Behavioral Associates, Staten Island

10605

The Burke Rehabilitation Hospital, White Plains

10962

Nathan S. Kline Institute for Psychiatric Research, Orangeburg

12205

Upstate Clinical Research, LLC, Albany

13088

Neurological Care of Central NY, Liverpool

14226

Dent Neurological Institute, Amherst

15017

Paramount Clinical Research, Bridgeville

15243

Research Protocol Management Specialists, Pittsburgh

15601

Westmoreland Neurology associates, Inc., Greensburg

18104

Lehigh Center for Clinical Research, Allentown

19107

Thomas Jefferson University, Philadelphia

19320

Department of Veterans Affairs Medical Center, Coatesville

21208

Pharmasite Research, Baltimore

21601

The Samuel and Alexia Bratton Memory Clinic, William Hill Inc, Easton

22205

TLC Neurology, P.L.L.C, Arlington

22903

UVA Neurology, Charlottesville

23185

The Center for Excellence in Aging and Geriatric Health, Williamsburg

23226

Neurological Associates, Inc., Richmond

23230

Alliance Research Group, LLC, Richmond

27103

Clinical Trials of America, Inc., Winston-Salem

27710

Duke University Medical Center, Durham

28211

Alzheimer's Memory Center, Charlotte

32514

Integrity Research, LLC, Pensacola

32547

White-Wilson Medical Center, Fort Walton Beach

32806

Compass Research, LLC, Orlando

33009

MD Clinical, Hallandale

33021

Sunrise Clinical Research, Inc, Hollywood

33064

Quantum Laboratories Memory Disorder Center, Deerfield Beach

33308

Neurologic Consultants, PA, Fort Lauderdale

33407

Premiere Research Institute, West Palm Beach

33431

Clinical Research Studies Dept. of Clinical Science and Medical Education, Boca Raton

33445

Brain Matters Research, Inc., Delray Beach

33613

Stedman Clinical Trials, LLC, Tampa

33952

Neurostudies, Inc., Port Charlotte

34285

Center for Clinical Trials, Venice

37067

Psychiatric Consultants, PC, Franklin

37920

Volunteer Research Group, Knoxville

39401

Neurological Research Clinic, Hattiesburg Clinic, Hattiesburg

39564

The Neuroscience Center, Ocean Springs

45219

University Neurology, Inc., Cincinnati

45459

Valley Medical Research, Centerville

46202

Indiana University Medical Center, Indianapolis

46514

Elkhart Clinic, LLC, Elkhart

48035

Michigan Neurology Associates, P.C., Clinton Township

48201

Wayne State University/Detroit Medical center, Detroit

49442

West Michigan Clinical Research, Muskegon

53188

Independent Psychiatric Consultants, SC, Waukesha

55114

Orr & Associates Memory and Geriatric Behavioral Health Clinic, Saint Paul

60007

Alexian Brothers Neuroscience Institute, Elk Grove Village

63104

St. Louis University, St Louis

63117

Sky, LLC., St Louis

66160

University of Kansas Medical Center, Kansas City

66214

MidAmerica Neuroscience Reseach Institute, Lenexa

66502

Precise Clinical Research Solutions, Manhattan

68105

University of Nebraska Medical Center, Omaha

68510

Premier Psychiatric Research Institute, LLC, Lincoln

71103

LSU Health Sciences Center/Department of Psychiatry Psychopharmacology Research Clinic, Shreveport

71104

J. Gary Booker, MD APMC, Shreveport

72034

IHS Research Center Inc., Conway

75231

Future Search Trials, Dallas

76309

Grayline Clinical Drug Trials, Wichita Falls

77521

Jacinto Medical Group, PA, Baytown

77555

University of Texas Medical Branch, Galveston

78229

Innovative Clinical Trials, San Antonio

Radiant Research Inc., San Antonio

80014

Senior Care of Colorado, Aurora

85282

Clinical Research Advantage Inc./Neurological. Physicians of Arizona, Inc, Tempe

86741

Northwest Neuro Specialist, PLLC, Tucson

90502

Neuro Pain Medical Center, Fresno

Collaborative Neuroscience Network, Inc, Torrance

91403

California Neuroscience Research Medical Group, Inc., Sherman Oaks

92064

PCND Neuroscience Research Institute Inc./The Center for Memory and Aging, Poway

92374

Anderson Clinical Research, Redlands

92591

Viking Clinical Research Center, Temecula

92626

ATP Clinical Research, Inc., Costa Mesa

92701

Neuropsychiatric Research Center of Orange County, Santa Ana

92845

Collaborative Neuroscience Network Inc., Garden Grove

93720

Margolin Brain Institute, Fresno

94109

San Francisco Clinical Research Center, San Francisco

94705

East Bay Physicians Medical Group, Berkeley

97225

Cognitive Assessment Clinic, Portland

98405

Internal Medicine Northwest, Tacoma

01201

Neuroscience Research of the Berkshires, Pittsfield

07724

Memory Enhancement Center of America, Inc., Eatontown

07856

NeuroCognitive Institute, Mount Arlington

08903

UMDNJ-Robert Wood Johnson Medical Center, New Brunswick

08759

Alzheimer's Research Corporation, Paterson

08084

UMDNJ-School of Osteopathic Medicine Center, Stratford

08755

Memory Enhancement Center of NJ, Toms River

02914

Rhode Island Mood & Memory Research Institute, East Providence

05201

The Memory Clinic, Bennington

00959

Metro Medical Center, Bayamón

00918

INSPIRA Clinical Research, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY

NCT00948766 - Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44 | Biotech Hunter | Biotech Hunter