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Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION)


Study Overview

Record IDs:

ADEAR: IA0188, NLM: NCT00948766

Current Status:

No longer recruiting

Purpose:

This study will assess the efficacy of a higher dose of rivastigmine patch (15 cm2) compared to a lower dose of the rivastigmine patch (5 cm2), in patients with severe dementia of the Alzheimer's type.

Sponsor(s):

Novartis

Official Title:

A 24 Week, Prospective, Randomized, Parallel-Group, Double-Blind, Multi-Center Study Comparing the Effects of Rivastigmine Patch 15 cm2 vs. Rivastigmine Patch 5 cm2 on ACTivities of Daily Living and CognitION in Patients With Severe Dementia of the Alzheimer's Type (ACTION).

Principal Investigator(s):

Novartis Pharmaceuticals , 

Start Date:

July 2009

Anticipated End Date:

April 2012

Expected Enrollment:

712


Qualifications for this Study

Minimum Age Maximum Age Gender Accepts Healthy Volunteers? Disease Stage Inpatient/Outpatient
50 None Both No Late
Outpatient


Inclusion Criteria:

    * Diagnosis of probable Alzheimer's disease (AD) according to National Institute of Neurological Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
    * Mini Mental State Examination (MMSE) score of ≥ 3 and ≤ 12
    * Able to complete at least one item on the Severe Impairment Battery (SIB)
    * Residing with someone in the community or in regular contact with the primary caregiver
    * Ambulatory or ambulatory with aid


Exclusion Criteria:

    * Advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk
    * Patients currently residing in a nursing home
    * Any current medical or neurological condition other than AD that could explain the patient's dementia
    * Current diagnosis of probable or possible vascular dementia
    * Current diagnosis of severe or unstable cardiovascular disease
    * Current diagnosis of bradycardia (< 50 bpm), sick-sinus syndrome, or conduction defects
    * Clinically significant urinary obstruction
    * History of malignancy of any organ system within the past 5 years unless patient is verified to be in stable condition with no active metastasis
    * Current diagnosis of an active skin lesion/disorder that would prevent the patient from using a transdermal patch every day
    * Known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to rivastigmine, or to other cholinergic compounds

    Other protocol-defined inclusion/exclusion criteria may apply


Prohibited Medications:

    taken any of the following substances (At the time of the Baseline Visit (Visit 2))
    * Succinylcholine-type muscle relaxants during the 2 weeks prior to baseline
    * Lithium during the 2 weeks prior to baseline
    * Investigational drug during the 4 weeks prior to baseline
    * A drug or treatment known to cause major organ system toxicity during the 4 weeks prior to baseline
    * Rivastigmine (oral or transdermal patch), donepezil, galantamine, other cholinesterase inhibitors (e.g., tacrine, physostigmine, or pyridostigmine), other approved treatments for Alzheimer's disease during the 2 weeks prior to baseline
    with exception of stable treatment with memantine for at least 3 months before study entry (Visit 1)
    * Centrally acting anticholinergic drugs including tricyclic and tetracyclic antidepressants during the 4 weeks prior to baseline
    * Selegiline unless taken at a stable dose during the 4 weeks prior to baseline
    * Peripheral anticholinergics not taken at a stable dose during the 4 weeks prior to baseline



Study Description



Phase 4, Treatment, Randomized, Double Blind , Active, Parallel, Safety/Efficacy  Study

Intervention Type Name Manufacturer Classification
Drug rivastigmine transdermal patch (Exelon Patch) Novartis cholinesterase inhibitors


 

Study Contact

Name:

Novartis Pharmaceuticals 

Telephone:

862-778-8300

Email:


All U.S. Trial Sites:

State City Zip Code Location Contact
ArizonaGilbert,85234Clinical Research Advantage/Neuro. Physicians of Arizona, Inc
 
480-610-0177
ArizonaTucson86741 Northwest Neuro Specialist
 
520-742-1833
ArkansasConway 72034 IHS Research Center Incorporated
 
501-247-6439
CaliforniaBerkeley94705The Research & Education Inst. of Alta Bates Summit Med. Group
 
510-849-0417
CaliforniaCosta Mesa92626 ATP Clinical Research, Inc
 
714-277-4472
CaliforniaFresno93710 Margolin Brain Institute
 
559-299-1515
CaliforniaGarden Grove92845Collaborative Neuroscience Network
 
714-799-7799
CaliforniaLa Habra90631 Neurology Center of N.Orange County
 
714-879-7200
CaliforniaLos Angeles90033 University of Southern California-School of Medicine
 
323-442-7594
CaliforniaOceanside92056 The Neurology Center
 
760-732-0557
CaliforniaPoway92064 The Center for Memory and Aging
 
858-674-1289
CaliforniaRedlands92374 Anderson Clinical Research
 
909-792-9007
CaliforniaSan Francisco94109 San Francisco Clinical Research Center
 
415-673-4600
CaliforniaSanta Ana92701 Neuropsychiatric Research Center of Orange County
 
949-294-7599
CaliforniaSherman Oaks91403 California Neuroscience Research Medical Group, Inc
 
818-990-2671
CaliforniaTemecula92591 Viking Clinical Research Center
 
800-670-4960
CaliforniaTorrance,90502 CNS Network
 
ColoradoAurora80014Senior Care of Colorado
 
303-306-4357
FloridaBoca Raton33431 Florida Atlantic University
 
561-297-2185
FloridaDelray Beach33431 Brain Matters Research, Inc.
 
561-374-8461
FloridaFort Lauderdale33308 Neurologic Consultants, PA
 
954-776-9111
FloridaFort Walton Beach32547SJS Clinical Research
 
850-863-8169
FloridaHallandale Beach33009 MD Clinical
 
954-455-5757
FloridaHollywood33021Sunrise Clinical Research, Inc
 
954-981-3850
FloridaPensacola32514 Integrity Research, LLC
 
850-484-7556
FloridaPompano Beach33064 Quantum Lab. at N. Broward Memory Disorder Center
 
954-786-7331
FloridaPort Charlotte33952 Neurostudies, Inc.
 
941-764-0800
FloridaTampa33613 Stedman Clinical Trials
 
813-971-8311
FloridaVenice34285 Center for Clinical Trials, LLC
 
941-488-0124
FloridaWest Palm Beach33407 Premiere Research Institute
 
561-845-0500
IdahoIdaho Falls83404 Rocky Mountain Diabetes and Osteoporosis
 
208-528-9641
IllinoisElk Grove Village60007Alexian Brothers Neuroscience Institute
 
847-640-5605
IndianaElkhart46514 Elkhart Clinic, LLC
 
574-296-3286
IndianaIndianapolis46202Indiana University School of Medicine
 
317-274-9903
KansasKansas City66160 University of Kansas Medical Center
 
913-588-0685
KansasLenexa66214 MidAmerica Neuroscience Reseach Foundation
 
913-894-1500
KansasManhattan66502 Precise Clinical Research
 
785-217-6559
LouisianaNew Orleans70115 LSU Health Sciences Center/LSU School of Medicine
 
318-813-2072
LouisianaShreveport71104J. Gary Booker, MD APMC
 
318-227-9600
MarylandBaltimore21208 Pharmasite Research
 
410-602-0555
MarylandBaltimore 21224 John Hopkins Bayview Hospital
 
410-550-9054
MarylandEaston 21601 Shore Psychiatric Associates
 
410-820-4005
MarylandGlen Burnie 21061 Clinical Insights
 
410-768-2629
MarylandSalisbury21801 Delmarva Family Resources
 
410-334-6687
MassachusettsJamaica Plain02130 VA Boston Healthcare System
 
857-364-4812
MassachusettsPittsfield 01201 Neuroscience Research of the Berkshires
 
413-499-7128
MichiganClinton Township48035 Michigan Neurology Associates, P.C.
 
586-464-2026
MichiganMuskegon 49442 West Michigan Clinical Research
 
231-727-4369
MinnesotaSt. Paul55114Orr & Associates Memory and Geriatric Behavioral Health Clinic
 
612-281-5314
MississippiOcean Springs39564Gulf Coast Neurology Center
 
228-818-9620
MissouriSt. Louis63104 St. Louis University Hospital
 
314-977-4820
MissouriSt. Louis63117 St. Mary's Health Center
 
314-647-4488
MontanaMissoula59802 Montana Neuroscience Institute Foundation
 
406-329-2617
NebraskaOmaha68105U of Nebraska Medical Center
 
402-552-6005
New JerseyEatontown07724 Memory Enhancement Center of America, Inc.
 
732-263-0101
New JerseyManchester08759 Meridian Institute Aging/Alzheimer's Research Corp
 
732-657-6100
New JerseyNew Brunswick08903 UMDNJ-Robert Wood Johnson Medical Center
 
732-418-8468
New JerseySomerset08873 Princeton and Rutgers Neurology
 
732-246-1311
New JerseyStratford08084UMDNJ-School of Osteopathic Medicine Center
 
856-566-6843
New YorkAlbany12205 Upstate Clinical Reserach, LLC
 
518-533-1546
New YorkAmherst14226 Dent Neurological Institute
 
716-250-2008
New YorkLatham,Neurological Research Center
 
518-785-1000
New YorkStaten Island 10305 Behavioral Medical Research of Staten Island
 
718-351-1806
New YorkStaten Island10312 Richmond Behavioral Associates
 
718-227-1897
New YorkSyracuse13210 Neurological Care of Central NY
 
315-701-4554
New YorkWhite Plains10605 Burke Medical Research Institute
 
914-597-2476
North CarolinaDurham27705 Duke University - Dept of Neurology
 
919-668-1538
North CarolinaWinston Salem27103 Clinical Trials of America
 
336-768-3456
OhioCenterville45459Valley Medical Center
 
937-208-8298
OhioCincinnati45267 University of Cincinnati
 
513-475-8781
OregonPortland97225Providence Brain Institute Cognitive Assessment Clinic
 
503-216-2736
PennsylvaniaAllentown18104Lehigh Center for Clinical Research
 
610-820-0342
PennsylvaniaBeaver15009 Tri-State Medical Group
 
724-774-7743
PennsylvaniaCoatesville19320Coatesville VA Medical Center
 
610-384-7711 ext.5729
PennsylvaniaGreensburg15601Westmoreland Neurology
 
724-836-1921
PennsylvaniaPhiladelphia19107 Thomas Jefferson University, Dept. of Phsyciatry & Neurology
 
215-503-1243
Rhode IslandEast Providence02914 Rhode Island Mood & Memory Research Institute
 
401-435-8950
TennesseeNashville37208 Meharry Medical College
 
615-327-6884
TexasBaytown77521Jacinto Medical Group
 
281-425-3840
TexasDallas75231 FutureSearch Trials
 
214-369-2600
TexasGalveston 77555 University of Texas Medical Branch
 
409-772-8068
TexasSan Antonio78229 Innovative Clinical Trials, Bexar Diagnostic Medicine Assoc
 
210-377-2873
TexasSan Antonio78229 Radiant Research - San Antonio
 
210-614-7483
VirginiaArlington22205Integra Trials Llc
 
703-528-0385
VirginiaRichmond23226 Neorological Associates
 
804-288-2742
VirginiaRichmond 23230 Alliance Research Group, LLC
 
804-353-4494
VirginiaWilliamsburg 23185 The Center for Excellence in Aging and Geriatric Health
 
757-220-4751
WashingtonSeattle98144 Pacific Medical Centers
 
206-621-4391
WashingtonSeattle98108 Veterans Affairs Puget Sound Health Care System
 
206-764-2339
WashingtonTacoma98405Internal Medicine Northwest
 
253-882-1081
WisconsinWaukesha53188Independent Psychiatric Consultants, SC
 
262-513-0700


Trial Sites Outside U.S.:

Country State City Zip Code Location Contact
Puerto Rico Bayamon 00959 Caribbean Education and Research Center
 
+1 787 786 0575
Puerto Rico San Juan, 00918 INSPIRA Clinical Research
 

 

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