AzTrials
AzTrials

Alzheimer's DiseasePhase 4ACTIONNCT00948766

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

A Phase 4 study testing Rivastigmine 4.6 mg/24 h (5 cm^2), Rivastigmine 9.5 mg/24 h (10 cm^2) and Rivastigmine 13.3 mg/24 h (15 cm^2) in people with Alzheimer's Disease, run by Novartis at 95 sites in 2 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 core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h transdermally (15 cm^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h transdermally (5 cm^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a 24-week study. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Rivastigmine 4.6 mg/24 h (5 cm^2), Rivastigmine 9.5 mg/24 h (10 cm^2) and Rivastigmine 13.3 mg/24 h (15 cm^2)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
716 participants
Where
95 sitesin 2 countries
Study dates
Jul 2009to Jun 2012
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • A Mini-Mental State Examination (MMSE) score of ≥ 3 and ≤ 12.
  • Be able to complete at least 1 item on the Severe Impairment Battery (SIB).
  • Residing with someone in the community or in regular contact with the primary caregiver.
  • Be ambulatory or ambulatory with aid.
  • Complete the double-blind phase (Week 24) of the core study.
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  • Provide, if mentally competent, a separate written informed consent prior to participation in the extension study. In addition, the patient's caregiver, will provide written informed consent prior to the patient's participation in the open-label extension study. If the patient is not able to provide written informed consent, written informed consent must be obtained from the legally authorized representative on the patient's behalf.
  • Continue to reside with someone in the community or in regular contact with the primary caregiver; patients who reside in an assisted living facility are eligible to participate.
  • Continue to have a primary caregiver willing to accept responsibility for supervising treatment (eg, application and removal of the patch daily at approximately the same time of day), assessing the condition of the patient throughout the extension study.
  • Must be medically stable and tolerating the current dose of rivastigmine patch as determined by the investigator.

Who cannot join

  • An 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.
  • A current diagnosis of probable or possible vascular dementia.
  • A current diagnosis of severe or unstable cardiovascular disease.
  • A current diagnosis of bradycardia (< 50 beats per minute [bpm]), sick-sinus syndrome, or conduction defects.
Show all 24Show fewer
  • 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.
  • A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to rivastigmine, or to other cholinergic compounds.
  • Taken any of the following substances (at the time of the Baseline Visit [Visit 2]).
  • Succinylcholine-type muscle relaxants during the previous 2 weeks.
  • Lithium during the previous 2 weeks.
  • An investigational drug during the previous 4 weeks.
  • A drug or treatment known to cause major organ system toxicity during the previous 4 weeks.
  • Rivastigmine (oral or transdermal patch), donepezil, galantamine, other cholinesterase inhibitors (eg, tacrine, physostigmine, or pyridostigmine), or other approved treatments for Alzheimer's disease during the previous 2 weeks, 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 previous 4 weeks.
  • Selegiline unless taken at a stable dose during the previous 4 weeks.
  • Peripheral anticholinergics not taken at a stable dose during the previous 4 weeks.
  • Extension study
  • Refer to the core study protocol for full details of the exclusion criteria.
  • Patients who discontinued the core study due to any reason are excluded.
  • No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
  • Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial locations and contacts

95 sites in 2 countries.

95 sites in 2 countries

United States93 sites

  • Upstate Clinical Research, LLC

    Albany, New York, 12205

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Dent Neurological Institute

    Amherst, New York, 14226

  • TLC Neurology, P.L.L.C

    Arlington, Virginia, 22205

  • Senior Care of Colorado

    Aurora, Colorado, 80014

  • Pharmasite Research

    Baltimore, Maryland, 21208

  • Jacinto Medical Group, PA

    Baytown, Texas, 77521

  • The Memory Clinic

    Bennington, Vermont, 05201

  • East Bay Physicians Medical Group

    Berkeley, California, 94705

  • Clinical Research Studies Dept. of Clinical Science and Medical Education

    Boca Raton, Florida, 33431

  • Paramount Clinical Research

    Bridgeville, Pennsylvania, 15017

  • Valley Medical Research

    Centerville, Ohio, 45459

  • Alzheimer's Memory Center

    Charlotte, North Carolina, 28211

  • UVA Neurology

    Charlottesville, Virginia, 22903

  • University Neurology, Inc.

    Cincinnati, Ohio, 45219

  • Michigan Neurology Associates, P.C.

    Clinton Township, Michigan, 48035

  • Department of Veterans Affairs Medical Center

    Coatesville, Pennsylvania, 19320

  • IHS Research Center Inc.

    Conway, Arkansas, 72034

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Future Search Trials

    Dallas, Texas, 75231

  • Quantum Laboratories Memory Disorder Center

    Deerfield Beach, Florida, 33064

  • Brain Matters Research, Inc.

    Delray Beach, Florida, 33445

  • Wayne State University/Detroit Medical center

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

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

    Easton, Maryland, 21601

  • Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey, 07724

  • Alexian Brothers Neuroscience Institute

    Elk Grove Village, Illinois, 60007

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514

  • Neurologic Consultants, PA

    Fort Lauderdale, Florida, 33308

  • White-Wilson Medical Center

    Fort Walton Beach, Florida, 32547

  • Psychiatric Consultants, PC

    Franklin, Tennessee, 37067

  • Neuro Pain Medical Center

    Fresno, California, 90502

  • Margolin Brain Institute

    Fresno, California, 93720

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Collaborative Neuroscience Network Inc.

    Garden Grove, California, 92845

  • Westmoreland Neurology associates, Inc.

    Greensburg, Pennsylvania, 15601

  • MD Clinical

    Hallandale, Florida, 33009

  • Neurological Research Clinic, Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Sunrise Clinical Research, Inc

    Hollywood, Florida, 33021

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • MidAmerica Neuroscience Reseach Institute

    Lenexa, Kansas, 66214

  • Premier Psychiatric Research Institute, LLC

    Lincoln, Nebraska, 68510

  • Neurological Care of Central NY

    Liverpool, New York, 13088

  • Precise Clinical Research Solutions

    Manhattan, Kansas, 66502

  • NeuroCognitive Institute

    Mount Arlington, New Jersey, 07856

  • West Michigan Clinical Research

    Muskegon, Michigan, 49442

  • UMDNJ-Robert Wood Johnson Medical Center

    New Brunswick, New Jersey, 08903

  • Eastside Comprehensive medical Center, LLC

    New York, New York, 10021

  • The Neuroscience Center

    Ocean Springs, Mississippi, 39564

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68105

  • Nathan S. Kline Institute for Psychiatric Research

    Orangeburg, New York, 10962

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Alzheimer's Research Corporation

    Paterson, New Jersey, 08759

  • Integrity Research, LLC

    Pensacola, Florida, 32514

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Research Protocol Management Specialists

    Pittsburgh, Pennsylvania, 15243

  • Neuroscience Research of the Berkshires

    Pittsfield, Massachusetts, 01201

  • Neurostudies, Inc.

    Port Charlotte, Florida, 33952

  • Cognitive Assessment Clinic

    Portland, Oregon, 97225

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

    Poway, California, 92064

  • Anderson Clinical Research

    Redlands, California, 92374

  • Neurological Associates, Inc.

    Richmond, Virginia, 23226

  • Alliance Research Group, LLC

    Richmond, Virginia, 23230

  • Orr & Associates Memory and Geriatric Behavioral Health Clinic

    Saint Paul, Minnesota, 55114

  • Innovative Clinical Trials

    San Antonio, Texas, 78229

  • Radiant Research Inc.

    San Antonio, Texas, 78229

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • Neuropsychiatric Research Center of Orange County

    Santa Ana, California, 92701

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California, 91403

  • LSU Health Sciences Center/Department of Psychiatry Psychopharmacology Research Clinic

    Shreveport, Louisiana, 71103

  • J. Gary Booker, MD APMC

    Shreveport, Louisiana, 71104

  • St. Louis University

    St Louis, Missouri, 63104

  • Sky, LLC.

    St Louis, Missouri, 63117

  • Behavioral Medical Research of Staten Island

    Staten Island, New York, 10305

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • UMDNJ-School of Osteopathic Medicine Center

    Stratford, New Jersey, 08084

  • Internal Medicine Northwest

    Tacoma, Washington, 98405

  • Stedman Clinical Trials, LLC

    Tampa, Florida, 33613

  • Viking Clinical Research Center

    Temecula, California, 92591

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

    Tempe, Arizona, 85282

  • Memory Enhancement Center of NJ

    Toms River, New Jersey, 08755

  • Collaborative Neuroscience Network, Inc

    Torrance, California, 90502

  • Northwest Neuro Specialist, PLLC

    Tucson, Arizona, 86741

  • Center for Clinical Trials

    Venice, Florida, 34285

  • Independent Psychiatric Consultants, SC

    Waukesha, Wisconsin, 53188

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • The Burke Rehabilitation Hospital

    White Plains, New York, 10605

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas, 76309

  • The Center for Excellence in Aging and Geriatric Health

    Williamsburg, Virginia, 23185

  • Clinical Trials of America, Inc.

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico2 sites

  • Metro Medical Center

    Bayamón, 00959

  • INSPIRA Clinical Research

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A 24 Week, Prospective, Randomized, Parallel-group, Double-blind, Multi-center Study (ENA713DUS44) Comparing the Effects of Rivastigmine Patch 15 cm^2 vs. Rivastigmine Patch 5 cm^2 on ACTivities of Daily Living and CognitION in Patients With Severe Dementia of the Alzheimer's Type (ACTION) and a 24-week Open-label Extension to Study ENA713DUS44

The core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h transdermally (15 cm^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h transdermally (5 cm^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a 24-week study. The extension study obtained additional safety and efficacy data, as well as provided the higher dose rivastigmine patch to all patients who completed the core study for an additional 24 weeks.

Being tested
Rivastigmine 4.6 mg/24 h (5 cm^2), Rivastigmine 9.5 mg/24 h (10 cm^2), Rivastigmine 13.3 mg/24 h (15 cm^2), Placebo
Keywords
Alzheimer's disease, dementia, Alzheimer's type
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

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

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

    Also called ENA713D, Exelon, Exelon patch

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

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

    Also called ENA713D, Exelon, Exelon path

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

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

    Also called ENA713D, Exelon, Exelon patch

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

  • PlaceboDrug

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

Study groups in NCT00948766
Study groupRoleWhat they receive
Rivastigmine 13.3 mg/24 h transdermal patchExperimentalIn the core study, patients were titrated to the rivastigmine 13.3 mg/24 h dose in 2 steps. For Weeks 1-4, patients received rivastigmine 4.6 mg/24 h. For Weeks 5-8, patients received rivastigmine 9.5 mg/24 h and placebo. For Weeks 9-24, patients received rivastigmine 13.3 mg/24 h and placebo. In the extension study, all patients were switched to rivastigmine 9.5 mg/24 h for a 4-week titration period and were then titrated up to 13.3 mg/24 h for a further 20 weeks of treatment.
Receives: Drug: Rivastigmine 4.6 mg/24 h (5 cm^2); Drug: Rivastigmine 9.5 mg/24 h (10 cm^2); Drug: Rivastigmine 13.3 mg/24 h (15 cm^2); Drug: Placebo
Rivastigmine 4.6 mg/24 h transdermal patchActive comparatorIn the core study, patients received rivastigmine 4.6 mg/24 h daily. For Weeks 1-4, patients received rivastigmine 4.6 mg/24 h. For Weeks 5-24, patients received rivastigmine 4.6 mg/24 h and placebo. No patients received this treatment in the extension study.
Receives: Drug: Rivastigmine 4.6 mg/24 h (5 cm^2); Drug: Placebo

What is being measured

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

  1. Core Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24

    The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a "yes" or "no" question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of "yes" reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement.

    Measured: Baseline of the core study to Week 24 of the core study

  2. Core Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24

    The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.

    Measured: Baseline of the core study to Week 24 of the core study

Secondary outcomes (5)

  1. Core Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24

    The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician's rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient's treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient's available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.

    Measured: Baseline of the core study to Week 24 of the core study

  2. Core Study: Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Score at Week 24

    The NPI-12 assesses a wide range of behaviors encountered in patients with dementia to provide a means of distinguishing the frequency and severity of behavioral changes over time. Ten behavioral and 2 neurovegetative domains were evaluated in an interview with the caregiver given by a mental health professional. The scale included both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 12 domains yielded the NPI-12 total score. The NPI-12 was scored from 0 to 144, with lower scores reflecting improvement in psychiatric behavior. A negative change score indicates improvement.

    Measured: Baseline of the core study to Week 24 of the core study

  3. Extension Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24

    The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a "yes" or "no" question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of "yes" reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement.

    Measured: Baseline of the core study to Week 24 of the extension study

  4. Extension Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24

    The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.

    Measured: Baseline of the core study to Week 24 of the extension study

  5. Extension Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24

    The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician's rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient's treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient's available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.

    Measured: Baseline of the core study to Week 24 of the extension study

Timeline

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

  1. First posted29 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJan 2012
  4. Study completionJun 2012

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
716 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00948766
Sponsor's protocol ID
CENA713DUS44
Acronym
ACTION
Status last verified
Aug 2013
First submitted
28 Jul 2009
Last updated
28 Aug 2013

Publications

  • Grossberg GT, Farlow MR, Meng X, Velting DM. Evaluating high-dose rivastigmine patch in severe Alzheimer's disease: analyses with concomitant memantine usage as a factor. Curr Alzheimer Res. 2015;12(1):53-60. doi: 10.2174/1567205011666141218122835.

    PubMed 25523430

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rivastigmine 4.6 mg/24 h (5 cm^2), Rivastigmine 9.5 mg/24 h (10 cm^2) and Rivastigmine 13.3 mg/24 h (15 cm^2) in people with Alzheimer's Disease, run by Novartis at 95 sites in 2 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 10 inclusion and 24 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 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 11 Feb 2013). 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?

Core Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24 (time frame: Baseline of the core study to Week 24 of the core study). 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 NCT00948766, which also lists 1 linked publication.

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 28 Aug 2013.

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